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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 55644 | 13 December 2021 05:00:00 | Agreement State | Missing THALIUM-201 Shipment | The following information was received from the Massachusetts Radiation Control Program (the Agency) via email: Lantheus Medical Imaging, Inc. notified the Agency at 1145 EST on 12/14/2021 that a thalium-201 (73.1 hr half-life) shipment in route to RLS USA, Inc. went missing in transit during vehicle maintenance operations. The vehicle had a flat tire that needed to be replaced. The flat tire occurred the early morning of 12/13/2021 around 0000 EST, but possibly before 0000 EST on the evening of 12/12/2021, (near Pallisades Park, NJ). During the tire change, the packages were removed from the vehicle in order to complete the maintenance. RLS USA, Inc. reported to Lantheus Medical Imaging, Inc. on the evening of 12/13/2021 that the thallium material was not received. A Tc-99m generator package shipped in the same vehicle was received by RLS USA, Inc. as part of the delivery, but the thalium-201 package was not received. The missing package contained 117 mCi of thalium-201 as of 12/12/2021 (Yellow II package, 0.3 TI). The reporting requirement is within 30 days and is of 105 CMR 120.281(A)(2), missing licensed radioactive materials in aggregate quantity equal to or greater than 10 times quantity specified in 105 CMR 120.297, Appendix C. The Agency considers this event to be open. New York State and New Jersey Agencies were contacted.
The following information was received from the Agency via e-mail: Correction: Lantheus Medical Imaging, Inc. reports that the flat tire on the delivery vehicle occurred at 6:45 PM on 12/12/2021. Correction: The event was reported to the Massachusetts Radiation Control Program at 11:45 a.m. on 12/14/2021 (the 11:45 p.m. in the narrative is a typo and should be a.m.). MDS performed searches for the package (where the flat tire was changed) and surrounding areas, performed searches at another location on the delivery route (MDS warehouse located in Little Ferry, NJ) and contacted other facilities on the route where other packages were delivered. The package continues to be missing. Notified R1DO (YOUNG), NMSS Events Notification group (email), and ILTAB (email). THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf | ||
| ENS 48486 | 1 September 2012 05:00:00 | Agreement State | Agreement State Report - Missing Package Containing Ga-67 | The following was received from the Commonwealth of Massachusetts via fax: On September 1, 2012, (a common carrier) notified Lantheus that a package was missing. The Yellow III package, containing 175 mCi of Ga-67, was shipped on 8/30/12 from Lantheus and destined to Bogota, Colombia. The package was received in Miami on 8/31/12, but never scanned out of Miami. (The common carrier) believes the package shipped unmanifested to Bogota. The licensee agreed to write a follow-up report. Docket Number: 22-0446 THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf This source is not amongst those sources or devices identified by the IAEA Code of Conduct for the Safety & Security of Radioactive Sources to be of concern from a radiological standpoint. Therefore is it being categorized as a less than Category 3 source | ||
| ENS 47867 | 14 March 2012 04:00:00 | Agreement State | Massachusetts Agreement State Report - Missing Thallium-201 Shipment | The following information was obtained from the Commonwealth of Massachusetts via email: On 4/5/12, (the) licensee reported as missing a 1.78 GBq (48.1 mCi) Thallium-201 package that was shipped from its site on 3/12/12, was scanned in at the carrier's Nashville, TN, transportation hub on 3/13/12 and reported to the licensee as missing by the carrier on 3/13/12. Licensee in communication with the carrier in ongoing effort to locate missing package. After a reasonable search time had passed, licensee reported missing package to this Agency (MA Radiation Control Program). Last known location was in Nashville, TN. The subject radioactive material is 7 ml of liquid solution held within a vial inside a lead pig inside a sealed plastic container inside a styrofoam insert within a corrugated cardboard box. Subject radioactive material has a 73 hour (~3 days) half-life and has decayed well past 10 half-lives since its original shipping date. Licensee remains in communication with carrier in ongoing effort to locate missing RAM and has requested return of package to licensee if found. The Agency considers this event to be CLOSED. THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf This source is not amongst those sources or devices identified by the IAEA Code of Conduct for the Safety & Security of Radioactive Sources to be of concern from a radiological standpoint. Therefore is it being categorized as a less than Category 3 source | ||
| ENS 46497 | 19 December 2010 05:00:00 | Agreement State | Agreement State Report - Delayed Medical Shipment | The following was received via email from the Commonwealth of Massachusetts: Licensee reported not receiving 400 Ci Mo-99/Tc-99m shipment from supplier on schedule (arrival originally expected for 12/18/10). Licensee is in communication with supplier and carrier(s) in ongoing effort to locate missing package. Last known location, per IRE (shipper), was Frankfurt, Germany. At 12/20/10, 8:30 AM ET, licensee received verbal confirmation confirming the shipment is still on the ground in Germany. Licensee has requested more definitive confirmation from its source(s). The Agency (Commonwealth) considers this event still OPEN.
The licensee stated that photographic evidence has been received confirming the shipment is still on the ground in Germany. The shipment will be returned to the supplier. The Commonwealth of Massachusetts considers the event to be closed. Notified R1DO (Perry), FSME (Burgess), and ILTAB (Whitney)
The Massachusetts Event Docket Number for this event is 12-9422. Notified R1DO (Perry), FSME (Villamar), FSME (Lewis) and ILTAB (Johnson) all via E-mail. THIS MATERIAL EVENT CONTAINS A "CATEGORY 2" LEVEL OF RADIOACTIVE MATERIAL Category 2 sources, if not safely managed or securely protected, could cause permanent injury to a person who handled them, or were otherwise in contact with them, for a short time (minutes to hours). It could possibly be fatal to be close to this amount of unshielded radioactive material for a period of hours to days. These sources are typically used in practices such as industrial gamma radiography, high dose rate brachytherapy and medium dose rate brachytherapy. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf This source is not amongst those sources or devices identified by the IAEA Code of Conduct for the Safety & Security of Radioactive Sources to be of concern from a radiological standpoint. Therefore is it being categorized as a less than Category 3 source. | ||
| ENS 45910 | 23 April 2010 18:45:00 | Agreement State | Agreement State Report - External Radiation Levels Exceed Limits | The following was received via email from the Commonwealth of Massachusetts: Lantheus Medical Imaging (LMI) received a customer complaint on 4/23/10 from a customer (GE Healthcare in Tampa, FL) reporting a reading of 310 mR/hr on a Tc-99m generator that was manufactured on 4/22/10 at the facility in Billerica, MA. On 4/27/10, LMI was able to clarify that the reading was on the package surface rather than on the generator itself. The customer reported the situation to the Florida Bureau of Radiation Control on 4/28/10. LMI has been investigating and have not yet found any evidence of a problem with this generator in their manufacturing records. LMI will continue to investigate and will be receiving the generator back from the customer in the next week or so. They will then examine it directly. The R1DO (Cook) and FSME (Suber) have been notified.
The Commonwealth clarified their report that the TC-99m generator is actually a Mo-99 generator. Notified R1DO (Gray) and FSME (McIntosh).
The following was received via fax from the Commonwealth of Massachusetts: This updated information is taken from Lantheus Medical Imaging letter dated June 11, 2010. Lantheus Medical Imaging received the generator back from the customer on 5/10/10 and performed tests and inspections on the unit. LMI found no evidence of any defect or condition that could have caused the high reading. Their radiation levels measured on 5/10/10 and back decayed for this generator on the day of manufacture was reported as 140 mR/hr. LMI reports there are only two scenarios to explain the high readings: 1, Migration of Tc-99m activity out to an unshielded section of the fluid path while the generator was in transit. LMI reports that this would involve an as yet unknown failure mode since all required fittings and plugs were in place at time of inspection of the returned generator. 2. The 310 mR/hr reading is in error, given that the customer reported a normal TI value, (i.e., 4.6 mR/hr measured vs. 5.2 mR/hr label value), a high reading Is difficult to explain, and the customer could shed no light on this apparent discrepancy. Based on the reported measurements of the returned generator which were back decay calculated to 140 mR/hr, it appears that the labeled TI value was correct. The customer's TI measurements agreed with the labeled TI value. The Agency (Commonwealth) considers this event to be closed. Notified R1DO (Joustra) and FSME (Villamar) |