ML20133N043
| ML20133N043 | |
| Person / Time | |
|---|---|
| Issue date: | 03/04/1975 |
| From: | Kerr G NRC |
| To: | Singer B NRC |
| Shared Package | |
| ML20133G976 | List:
|
| References | |
| FOIA-96-343 NUDOCS 9701230139 | |
| Download: ML20133N043 (15) | |
Text
'
c UNITED STATES f
NUCLEAR REGULATORY COMMISSION M
g W ASHINoTON, D.
C.
20555 MAR 4g 8
Bernard Singer, Chief Materials Branch Division of Materials and Fuel Cycle Facility Licensing SHIPPING INCIDENT INVOLVING A MALLINCKRODT Mo99/Tc99" GENERATOR Enclosed is the Texas investigation report on the subject incident.
Inasmuch as the report indicates there may be a design defect, will you please advise me of any action you plan to take in regard to this i
incident.
WS have advised Texas that you are taking appropriate action in regard to accurately describing the activity on the package and generator labels.
We plan to bring the packaging defect to the attention of DOT.
(lht
/
G. Wayn Kerr, Chief Agreements and Exports Branch Division of Materials and Fuel Cycle Facility Licensing
Enclosure:
As stated OWTIO4 h
%o#
\\
5 9
m
\\,,,.. j 9701230139 970114 PDR FOIA FLOYD96-343 PDR
l otate Department of wealth AUSTIN TEXAS INTER-OFFICE i
Edgar D. Bailey Incident File No..1033 rnou 78c:
Muclear Pharmacy, Inc. [8 I911 i
$UDJECT Spillage of Tc/Mo During Shipment License & Insp. Files At 11:55 a.m., D'ecember 16, 1974, I received a telephone call from i
Warren Fadling (314-291-0540), Health Physicist for Mallinckrodt, j
St. Louis, Missouri.
He reported that one of two 500 millicurie Tc fission product generators shipped to Nuclear Pharmacy, Inc., 3839 4
Morningside, Houston, was found to have leaked Mo/Tc outside the i
shielding of the generator. _Upon opening the package, a liquid (pos-sibly from the storage reservoir inside the generator) was observed in the plastic liner which is inside the styrofoam form and outer card-boardboxandinnerstyrofoamformshowednocontamination.] Liquid
'was radioactive, but it was not known if the liquid contained Tc or Mo.
I told Mr. Fadling that we would send someone down to check out the package, and I would let him know what we found out.
At 1:00 p.m. I asked Larry Stephenson and Richard Ratliff to go to Houston and investigate the incident.
At 1:30 p.m. I received a call from Robert L. Sanchez, Nuclear Pharmacy Inc.
He called to report that the radiation levels around the package using a 50 mr/hr GM survey meter were 50 mr/hr at 3' and was " pegged" at 2 feet from the surface.
Using a " Cutie pie" he obtained a surface reading of 250 mr/hr.
At 1:55 p.m. I called John Combi, City of Houston Health Department.
He was out so I left a message for him to telephone me.
At 3:35 p.m. I called Glen Brown, U. S. Atomic Energy Commission, Region IV, Fort Worth, (817-334-2841) and told him about the incident.
told him that we wauld keep them informed of our investigation I
findings.
Later I talked to Mr. Padling and told him that Larry Stephenson and Richard Ratliff were on their way to Houston to investigate.
}
o
!" ate Departmelit of r Jalth AUSTIN TEXAS INTER-0FFICE Edgar D. Bailey Incident File No. 1033
- ggg, To (cc:
Nuclear Pharmacy, Inc.
sua>EcT Continuation of Incident Report File & Insp. File 8-1911)
December 17, 1974 - At 1: 20 p.m. I received a call from Larry Stephenson and Richard Ratliff.
They said the package had read 500 mr/hr on contact at the sides and 1R/hr on the bottom last night when they arrived.
This morning the readings were 75 mr/hr and 150 mr/hr respectively indicating that the isotope involved was Tc-99m.
They said package had been shipped by truck to Dallas where it was transferred to Airborne Messenger Service who flew it to Houston by " charter" aircraft (Airbill No. AMS-2169).
There it was transferred to Roden Delivery who delivered it to Nuclear Pharmacy, Inc. around 1:00 a.m. Monday, December 16, 1974.
1 I telephoned Airborne Messenger Service at Dallas /Ft. Worth (214-574-5900) and was told that they did not have a " charter" flight to Houston on Sunday night.
They were unable to identify shipment without a better airbill number.
I telephoned Airborne Messenger Se rvice in Houston (713-641-0633)
(713-641-1323) and talked to Roger Bauer, business manager.
He said that the package was carried on a company cargo plane Flight No. 15-1274-04.
Flight numbers are broken down as noted:
15 12 74 04
~~
~
~ ~
~
~I flight of day year
- month
- day He said flight left D/FW around 6
- 00 p.m. and arrived in Houston around 8:00 p.m.
He also informed me that company personnel wore film badges (AEIL) when working with or transporting radioactive materials.
I asked him to have badges processed as soon as possible.
I told him that I would alert AEIL about the badges.
At 2:00 p.m. I called'Ms. Cheryl Miller at AEIL and explained need for film badge processing and asked that she telephone readings to me as soon as she could.
smnco /
. ~
.. ~
-. ~ -. - - -. -. -.. - - -..
j
. Continuation of Incident Report Incident File No. 1033
}
January 3, 1975 i
December 18, 1974 l.
At-ll:45 a.m. Mr. Fadling called and asked if we could have someone meet him at. Nuclear Pharmacy, Inc. the next morning to open up the generator to try to determine what had. happened.
I told him I j.
would phone him back and lot him know.
4 j'
,I requested that Richard Ratliff and John Haygood go to Houston.
They were told to talk to John Combi, City of Houston Health Department; Glenn Harris, U. S. Department of Transportation; and i
Sheri Miller, AEIL, about tihe incident.
l After lunch I called Mr. Fadling and told him that Richard Ratliff and John Haygood would meet him at Nuclear Pharmacy at 8:00 a.m.
the next morning.
At,2:35 p.m. I called Agreements and Exports Branch, U. S. Atomic Energy Commission, and talked to John McGrath.
I explained the incident to him and told him of our actions.
l At 3:20 p.m. I received call from Ms. Miller; she said all Airborne Messenger Service film badges but one had been processed.
She said that the highest two badges read 16 mrem.
One of these was Mr. Bauer's.
At 3 : 30 p.m. Mr. John Combi returned my earlier call.
I told him j;
of the incident and our actions.
At home at 5:35 p.m. I received a call from Martin C. Wukasch.
He said that a Mr. Vetler, Assistant to the Director, Region IV, U. S.
j'
-Atomic Energy Commission (817-275-6282) had phoned Dr. Peavy for information about the incident.
At 5:40.p.m. I telephoned Mr. Votler.
I told him that I had notified Mr. Glenn Brown of his office about the incident on Monday.
I told i
him about the incident'and our actions.
. December-2C6 1974 At 10:00 a.m.
I received a call from Mr. Lou Stone, Department of Transportation, Fort Worth.
I told him about the incident.
f.
i-
C. ate Department of Dalth AUSTIN TEXAS INTER OFFICE Richard A.
Ratliff Larry J. S tephenson Incident File No. 1033 FROM 7n(cc:
Nuclear Pharmacy, Inc.
Spillage of Tc/Mo During Shipment License'& Insp. Files 9-1911)
SU BJ E CT December 16, 1974 At1:0g7 p.m.,
as lirected by Edgar D. Dailey, Larry J. Stephenson and myse4f departed Austin to investigate a damaged shipment at Nuclear Pharmacy, Inc., 3839 Morningside, Houston, Texas.
We arrived at Nuclear Pharmacy at approximately 5:45 p.m. and met with Mr. Robert L. Sanchez.
The shipment in question was identified as follows:
Mallinckrodt Nuclear Ultra-Technekow FM (Technetium 99m Generator)
Item 105 500 mci (99 o) calibrated for 8:00 E.S.T.
M 20 December 1974 105-4LL Exp. 27 December 1974 (See attached Mallinckrodt Nuclear technical product date pamphlet for this type generator.)
The shipping papers for this shipment included the following information:
Date Shipped - December 13, 1974 Cust.'P.O. # 13359 Invoice # K360458 Control # 0011884 Cust. No. C6391 Airport Code.DRD/IAH From:
Mallinckrodt Nuclear, 463 Rarell Ave.
Carlstadt, New Jersey 07072 Generator 41 The package was labeled as follows:
Radioactive Yellow III, Transport Index 3.6 500 mci Mo99
)
I unnrn, -
c Incident No. 1033 Page Two The generator and package were then surveyed using a Frieseke
& Hoepfner Model 40TLS survey meter HEA # 28649, last calibrated April 1974 using a Cesium 137 check source.
This meter has a G.M. tube' type FHZ-76V which has a correction factor of 0.48 for
'140 Kev energy.
The survey of the package at 6:00 p.m. rendered the following readings:
Surface of Package - (sides) 500 mr/hr*
Bottom of Package - 1,000 mr/hr*
38 from Sides of Package - 13 mr/hr*
Wipes were then taken on the outside of the package using Whatman 1 filter papers.
A wipe of the bottom of the package showed no radiation levels above background as did wipe of the sides of the package.
A, wipe of the inside packaging material (refer to Incident photographs 1 & 2 for view of package) revealed radiation levels of 25 mr/hr using the F & H 40 TLS GM survey meter.
The package and generator were placed in Nuclear Pharmacy s hot waste storage area.
8 December 17, 1974 Returned to Nuclear Pharmacy, Inc. at 8:00 a.m. and re-surveyed j
- the package and obtained the following results:
. Surface of Side of Package - 75 mr/hr*
Bottom of Package - 150 mr/hr*
Wipes of the Inside of the Package - were down to i
less than 1 mr/hr*
l It was then concluded that the contamination in the package was Technetium 99m.
The samples were taken to our Austin laboratory for confirmation which was verified that afternoon.
I
- not corrected for energy response of meter J'
l t
5..
J g
,vp.,-
_ _... -~_ -
m
.._m l
I r. c l itse l et st:.t how s h tr.nsta m L
- h., wrier wrs u.t.m the N'
N I
t W*9 l
l t
following amount cf mol bdenum-99 at the time of colibration stated N UCLE A R >
I i
t o
o, the label.
/
l Catatoc Nu-ber o
o i
I 006 50 mal! curies 007 100 mittacurses
" # C"#
- C""*C"""*
O 012 150 millicuries 008 30 mailicuries O
O P09 300 m.Itacurses 010 400 mitticuries
~.
Of1 MO n s!!icurses oI O,
r 4 i The t!!tra-Tectmchom Fil (Technetium Tc 99m) Generators contain the h
idlowing amount cf mol>bdenure-99 at the time of calibration stated i
en the label.
t Ceal-g Nimber l
Ultra-TechneKowS
- di i
4 100 30 mt!!a. curses Iri i
101 100 rnstt: curies Ultra-TechneKow@ FM
'l i
[,fj [,['""*'
(Technetium Tc99m Gene-stor) 103 300 millicurses For the Production of Sodium Pertechnetate Tc 99m 104 400 millicuries Q
105 500 rraiticuries y
Exh rer:erator as supplied with the folicwtng components for the elution j
af the reneratcr.
D E SC RIP TIO N d
6 - Sterile. Craduated, evacuated col!ceting vials The l'Itra Technehow Generator is prepared with mol> bdenum 99 which p
l 6 - Sterile Lucr-Lock needles with plastic covers is produced by arradiation of stable molybdenum. The l'Itra-Tec hnchow ga l
Fht Generator is prepared with fission produced molybdenum 99. Bcth c'
generators provide a closed system for the production of sterite meta-M 6 - Pressure-sensitive Caution - Radioactive Material ** collect r g vial 1.bels stable technetium 99m. which is produced by the decay of mo! bdenum-h l
3 j
6 - Pressure-sensitive radioassay data labels for 99 Sterile, pyrogen-free isotonic solutions of Sodium Pertechnet a t e 1
(
Icad dispensing shield Tc 99m can be obtained conveniently by periodic asept:c clution of the C'"*
h T VACUATED COLLECTING VIALS. Cc,1lecting vials are available on f
rt ga n in 5.10, 20 and 30 malls! ster sizes.
The generators consist of scaled glass chambers containing specially processed alumina. This treated alumina has a high adscrption capasty l
Dl5POSAL for mo!>bdenum 99 and a low affinity for technetiur i-90m. A s a remalt, p
~
elution of the generator yselds a sctution of te shnc tium 49n. containing F o!!ne. sng use. the antact ge nera t or a s sembly should be placed in an negligible amounts cf n.o!>bdenum 99
.g prc;rsate radicas.tave storage area and a!! owed to decay. In general, the sterage tame sho.ald be at least 15 half-lives of the molybdenum-99 ACTIONS or bout 42 d u s.
i The pertechnetste ion distributes in the body similartly to the iodide j
ion but is not organified when trapped in the thyroid gland. Pertechne.
l t
tate tends to accumulate in intracranial lesions wath excessive neo-vascularity or an altered blood-brain barrier. It also concentrates in 91 thyroid gland, salivary glands, stomach and choroid plexus. After intra-(
vascular administration it remains in the circulatory system for sufficient
=
time to permit blood pool. organ perfusion, and major vesset studies.
It gradually equilibrates with the extracellular space. A fraction is promptly excreted via the kadneys.
i
- ?
t.* C W-20:3 3. R P n ewed in t).5, A, b
8 I
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, ;. a vd in itnc.
sa! vary g! nd : r. aging, p!au nta locaiaation and blood pool imararig.
DIRECT;oNS FOR tJ5E O F TEC l fer.:-la ch" haw eD p.j CON TR Alt! DICA TlONS bitfa let hnchow n1 GENERATORS
%n e.
U First Elve.on yj
- i. 4
- 1. R.tse nc6 cr p!,p r a n d a t.t. h :_ e are pregncnt or dur ng laet.rten r.!ess :he anf:rraatsen to be carned net d.e and v. :wn :he,erdw i.ard i: r "8:#-.. ser.e Luer.._ m L
(
cut we:g.hs he potential hazar ds.
1 P s
ir v:a! m i+ e r!unca
- hicht n. t h.h: th+ -! rradatiens Idrally, e xa m tnaison s usteg radiopharrr. ces;tscals, especially those
.g gj g3
- y.,,3,,y, y..sg 3 3,,n ; 3 33, ab.v:* &an -N.-r elstm.
- cc!N :r+ s t.
sit
_5
- s pi a c v4.b.
electit e an nature, of a
.m an af chmidbearing capabthty shouM be
[{[
perf ormed durang t?.e first few (approx ima t el y 10) days followsng the en s e-cf mensca p
p%
R.adiopharmace.;: eals should t<e used only b.y physicians whe are quali.
p favd bs specafic training an tht safe use and hand!ir:g cif radaonuc!! des poduced by nuctear reactor c.r garticle accelerator and hose experience l
r.d t ascang have been appro.ed by the appropriate gos emment
[
agenc5 l
auth0 rued to license the use, of radsent.c!: des.
7',
k,g p g,,, g, i
Q g
1 P R ECAUTIONS Typical decay c u rv e
/
t' hr L
for moly bde aum49
-s As in the use of rny other ri.deo ctive nieternal, c.rc shculd be ta'n en
(
[
and oc c he rium.99 m ic insure n:nir um radiation expost:re to the patient. censistent with prcer p.s t iert manager ent, and tc insure inanamum radiatic,n exposure bu e.ld sp
- curves, o
. }'
pan na; e.crLers.
g l
^
v g
e, s
s bo.,i n g. Hec
- of
/\\
l y,. Tc a:
s a,c of a dminis t ra t acn the so!ution shculd be crystal clear.
do.ly ei s tio n of o
/
Mi i
c:
sec hn e tsu m.99 m.
]
1 A0 VERSE REACTIONS j
f
- f'
{
j None.
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l COSAGE st4D ADMiritSTR ATION i
1, I
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r Sc,cMum potechnerate Tc.99: is us ually adwntstered by int rarascular I
t l
+
injection but can be given ers!!v. The desat:e employed varies verth i
8 I
i cach d;arnostic procedure.
1 2
3 4
5 6
/ g le suggested dase range er p!osed for varicus diagnostic indic tens
- Doy3 -
j t :he as erage patient GO kg) is:
g g,,;.,,
brain imag:ng: 10 to 20 r Ci g
,n,,
,,,g L
- .nder he needle.
thyroid cl. sod ir,:rgang: 1 to 10 mC 4 pt,,,,.,, eg,3 n.w r p:;...e. c g. pi
.,.:v
,,7 ! r ' s.. :
S e l ts. x i o salivary gland am.ging: 1 to 5 mci c
placenta localization: 1 to 3 mci s c, lock an pt. sin r_
Tne at t renst.r e. e dit : :h:5 a s
.c wm hie el j
piercred the ruH.e c.;c-arc s f ths c.-6 eu. t. d. ' tt e !"eq s aa ? and :'
- blood pool imagtng: 10 to 20 mci in t h's
~
j etu: ion procedure will be in procress. ti the plunver i* left y(> TF.- U; to I g om of reagent g-adr ;oeass eum pere!.terare en a s unsa.
pos: tion. th<. e lut aen wilt t ent anut until r e,3 :s t ie r Th -e le:.d g!an l
i 65 'ast or
'*" m w raceceipa ute n.as, be oi,en oralty prior to a dm.as seration of.todiu=,
window of the clo:ien :,hield alf ews s isa I det e rm.n.eiori og tga rc 99
..j,ce,,o f,, 6ra se. imassas. placenca locatriarao.
cluate s olume, and the sic::en proes s s may be s:.'rpc t
- a. ant
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Volurr.e desirt,d by role 3 sink the pi a n ga e r.
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- h e. rer u o p.*:.st es.+ ed:<. erce frem <ti= penser t ra.. 99:n rr crco ar. c w !i c. t.r.*
f or r r.-
H-
- ' nt : ca.unts.
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8 e
3'
a
- I cm. i t.c r....ala.a y e r a s e.:. : -. r, c's.
(T+ C?n net c e *) 11.u05
- l ')'L, - " 7'.
' " P' D.
To correct for physical decay of this radienuclide, the per:ertages : hat (J t W: ( t :- < yr -- C. C.
.U.
.r r br.:
remain at selected interests are shown in Table II.
'*b t%
i:
7. ns t k f..- i bc a r-art ef r.c.h t,s'. n a-.**** rees e ti ser :h r ulse he s.-ht M
..r. !. svr >n t he s e; 'er t r :ht n?O NV N.se 1e. el ne:t ua venth the uger To* ole li. Physicot Decoy Chare; Tecknetiurn 9h, hamnie 6.0 heves
.-! *.:m.1 ci f T.w
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ed 780 kev Ml l e 5'i < f the c:=ints. raisons. v il: inen L e n eer.ted w ith l
N.,ves
" Renciand N%rs O A' u*J c-m% ra s s in l
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's h.'<taa-. "?r.. 140
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39.7
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35.4
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100.0 10 31.5 i
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$ 9.1 11 2S.1 j
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R ADI ATION DOSIMETRY
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l Late Departmalit of I.salth AUSTIN TEXAS 4
l INTER 0FFICE i
Richard A. Ratliff John R. Haygood Incident File No. 1033 g g, 7g Tec:
Ndclear Pharmacy, Inc.
f Spillage of Tc/Mo During Shipment-License & Insp. Files 8-1911)
SUBJECT l
At 9:00 a.mt, December 19, 1974, Mr. Richard Ratliff and I met q
l with Warren Fadling, Health Physicist for Mallinckrodt, St.
Louis, Missouri, at Nuclear Pharmacy, Inc., 3839 Morningside, Houston, for the purpose of further investigation of the leaking of Mo/Tc from a Mallinckrodt 500 millicuric Tc fission product generator while in transit from the manufacturer to Nuclear Pharmacy, Inc.
Mr. Robert Sanchez of Nuclear Pharmacy was also present.
We determined that the shipping route was as follows:
The generator was shipped from Mallinckrodt Nuclear, Carlstadt, New Jersey, at 4:45 p.m. on December 13, 1974, to Mallinckrodt, St. Louis, Missouri.
It was then shipped j
from the St. Louis plant by Purolator Carrier Corporation l
truck to Oklahoma City.
The generator was transferred to another Purolator truck and was transported to Dallas, arriving at about 6:00 p.m.
Airborne Messenger Service picked up the generator and flew it by small, unpressurized aircraft to Houston.
The time of departure was 7:00 p.m.
on December 15, 1974.
The altitude flown was 4,000 feet, 3
)
and time of arrival in Houston was 8:00 to 8:15 p.m. on i
the same date.
l The generator was estimated to be about a minimum distance of four (4) feet away from the pilot during the t
flight.
The pilot (Norvell Neitzke) had a film badge j
reading of 10 mrem.
Roden Delivery Service picked up the generator at 8:45 p.m.,
December 15, 1975, and delivered it to Nuclear Pharmacy in Houston at 9:25 p.m. the same day.
Leakage of.the generator was discovered by Robert Sanchez of Nuclear Pharmacy at about 3:30 a.m. on December 16,-1974.
On our examination of the shipping container and generator on December 19, 1974, (see incident photographs 1, 2,
& 3) very little activity remained indicating that no Mo99 had leaked.
Mr. Warren Fadling disassembled the generator casing and the apparent source of the leak was discovered (see incident photo-graphs 4 & 5).
A small leak was found in the tubing which carried the eluant from the " moly" column to the needle from which the Technetium 99m is extracted (see incident photograph 6.j
/1// w / '/.
l Incident File No. 1033 Page Two The leak occurred at,a point such that the plunger spring caused the eluant to escape through the plunger opening instead of flowing into the generator casing.
It was theorized that the decrease in, pressure, when the generator was flown from Dallas to Houston, caused the elution to occur.
Mr. Fadling removed j
the tubing, plunger, and needle to return them to the Mallinckrodt plant for evaluation.
f Mr. Norm Miller, FAA, Houston Hobby Airport, was then contacted and informed of the investigation.
He stated that the plane used by Airborne messenger Service was a cessna 205, Number N8422Z, and the pilot's name was Norvell V. Neitzke.
We informed Mr. Miller that there had been no external contamina-tion from the leak and he requested that we send him a copy of the final incident report for FAA files.
Mr. Miller's address is:
FAA - Houston GADO 58800 Paul B. Koonc Drive Room 152 Houston, Texas 77017 cc:
Nuclear Pharmacy License File (8-1911) cc:
Nuclear Pharmacy Inspector's File (8-1911)
i a4, PICTURES FROM INCIDENT NO. 1033 l,
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I ~ l ~ i i i i \\ i s l .a I ) 1 Tc 99m Generator, December 17, 1974, Nuclear Pharmacy, Inc., i Houston, Mallinckrodt-Ultra-Technekow Generator package. ( l i t . c.,.1 y;i..p :n,. u l ~ \\ . ' 4: q 5 i 1 I' t \\ Iv L \\ .g ,4f n, ~ l %;M.% 2. Tc 99m Generator, December 17, 1974, Houston, inside generator package of leaking generator. ~ ' ' - -
j l j PICTURES FROM INCIDENT NO. 1033 i 1
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. ) \\ \\ i &: ~ 3 r ,%f l t '. 3 1.,,(- l d 3 i W s $ s e[ l f L 3. Leaking Tc 99m Generator, Mallinkrodt Nuclear, Ultra-Technekow FM Generator, December 19, 1974. ,k . ppd i l .g, i f i- .e 4. Leaking Tc 99m Generator, December 19, 1974, Mallinkrodt Nuclear, inside leaking Ultra-Technekow Generator - NOTE: salt deposit on spring from leaking sodium pertechnetate. i l l
1 j. .CTURES FROM INCIDENT NO. -,33 !Je i .,4,, i 7fjMg!;.',.5sQ,~. Yh_.k...i 'N(f t,, ) ^NI.fp 17!. 4 ?'% h*J,. l 3, ff:Y 9 M g O}.! 1 ) hl ),h W.i GJ f idl I? i g%u i ,Kf.;).>. *j ' \\. ~ 4 I k etDyrJd.,,, l5& ; p*?pY,. Ihd , :f'I's I ~ l j 5. Leaking Tc 99m Generator, December 19, 1974, Mallinkrodt { Nuclear, top view of inside of leaking generator. i e l q; I NY Y' \\ R. y;5.,, { \\ 'i [,,My' ?/gj
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\\ o L t l 6 Leaking Tc 99m Generator, December 19, 1974, Mallinkrodt Nuclear, close-up of plunger assembly of leaking generator - l tubing extending forward had been cut by spring assembly, i . -.. -}}