IA-84-720, Requests Addl Info Re Model 6701 Seeds Containing I-125. Copies of Warning Notice & All Other Instructions & Package Inserts,Notification of Any Mod to Seed Design or Mfg Process & Any New Test Data Re Seed Handling Requested
| ML20126C378 | |
| Person / Time | |
|---|---|
| Issue date: | 09/24/1982 |
| From: | Jim Hickey NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Copeland F MINNESOTA MINING & MANUFACTURING CO. (3M CO.) |
| Shared Package | |
| ML20126C180 | List: |
| References | |
| FOIA-84-720 NUDOCS 8506140399 | |
| Download: ML20126C378 (2) | |
Text
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.8 SW ? L Yg; FCP1:JH Hinnesota Mining and Manufacturing Company ATTN: Mr. Frank S. Copeland 3M Center St. Paul, Minnesota 55144 Gentlemen:
This is a follow-up letter conceming your Model 6701 therapeutic seeds containing iodine-125. As you may recall, Mr. Earl Wright wrote to you on July 20, 1981 concerning events involving apparent leakage from these seeds. You replied on September 30, 1981, stating that a warning notice would be added to the shipping package. .
To our knowledge, no leakage incidents have been identified since you added the warning. However, we have continued to consider questions as to whether the iodine-125 seeds are prone to leakage, whether unidentified leakage incidents art centinuing to occur, and what additional steps, if appmpriate, could be taken to reduce the probability of leakage.. We are retaining a consultant to assist us in our evaluation.
3M has already submitted a large amount of documentation related to the 1-125 seeds. The purpose of this letter is to assure that we have complete, up-to-date information. Therefore, we would appreciate any information or coin nts with respect to the following: ,
- l. Warning Notice Package Inserts Currently provided with I-125 Seeds Your letter dated Septenber 30, 1981 indicates that you have added a warning notice to the 1-125 seed package. We do not have a copy of the waming notice on file. Please provide copies of the waming notice and all otner instructions and package inserts currently being provided with I-125 seeds.
- 2. Design Ibdification If 3M is planning any modification in the design or fabrication process of the Model 6701 seeds, or contemplating their replacement with a different model, we would appreciate being infomed about it as early as possible.
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- 3. Seed Handling We are examining the possibility that the risk of damage through mugh handling is excessive. 3M has already provided test data for impacts, percussion, and bends. We would appmciate being informed of any new test data which have not previously been sent to us. We would appreciate any casunents you might have as to why the seeds passed these tests, yet appear to have failed under rough handling conditions; for example, excess forcep pressum and forcing the seeds into or out of an app 11cator.
- 4. Leakage If 3M is aware of any leakage incidents involving Model 6701 seeds which occurred after September 30, 1981, please let us know. For perspective, please indicate appmximately how many seeds have been distributed since that date.
- 5. Quality Control Your quality control procedums specify length and external diameter checks, inspection of welds, leak tests, x-rays and asses. Them is no indication that production seeds are periodically sampled and subjected to impact, percussion, and bend testing similar to the prototype tests. Are such tests periodically performed on production '
seeds?
- 6. Medical Effectiveness Your letter dated September 30, 1981 implies that if the seeds were to be nada stronger, their medical effectiveness would be reduced by increased absorption. Please provide an/ detailed coments you may have with respect to problems that may be associated with making the seeds stronger.
We would appreciate it if we would receive your connents within 33 days.
Sincerely, DISTRIBUT10N f[,{BInc1 tien,g 3 JHickey # R. Ein, Y GTerry GTrager, AE00
- John W. fl. Hickey, Section Leader NMSS r/f FCMLB r/f Industrial Section FC Central File Material Licensing Branch FCMLB r/f Division of Fuel Cycle and Haterial Safety s /
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