ENS 48831
ENS Event | |
|---|---|
13:00 Feb 26, 2013 | |
| Title | Potential Loss of Brachytherapy Seeds |
| Event Description | On 2/25/2013, four Mick applicator kits with fifteen I-125 seeds in each applicator kit (60 seeds total) were shipped to the Dameron Hospital in Stockton, CA. Each seed contained 0.45 milliCuries. On 2/26/2013, 49 seeds were implanted with one seed jamming in the applicator. After the medical procedure, the radiologist stated that only 50 seeds were in the applicators i.e. ten missing. Surveys were performed but the missing seeds could not be found. The jammed seed is being returned to Biocompatibles.
The following detailed event text was received from the licensee (Biocompatibles, Inc.) via fax: Biocompatibles, Inc. ('Biocompatibles') has investigated a report that ten (10) I-125 sources (0.450 mCi each Ref date 2/26/13) that Biocompatibles sent to Dameron Hospital in Stockton CA (the 'Hospital') are unaccounted for. On February 26, 2013, Biocompatibles received a report that at the end of an implant procedure for which Biocompatibles provided (60) sealed sources in four (4) Mick magazines of fifteen (15) sources each that:
A Biocompatibles sales representative was present during most of the procedure performed on February 26, 2013 and reported that there was no indication that there were not four (4) full magazines of (15) sources each at the start of the procedure. In addition, the Hospital has confirmed that the decision to implant forty-nine (49) sources was made by the operating physician at the time of the surgery. Several communications led Biocompatibles to believe that the sources were accounted for at the Hospital, but on March 13, 2013, a conversation with relevant personnel confirmed that the Hospital did not have the sources. Biocompatibles received the sources from its Supplier on February 19, 2013, and loaded all sources received into four (4) magazines on the same day. Biocompatibles' production records confirm that Biocompatibles received sixty (60) sources from its Supplier (OPSRAD SOP09-01), and subsequently confirmed with its Supplier that exactly sixty (60) sources were sent to Biocompatibles. Biocompatibles verified the source counts at magazine loading. Biocompatibles also performed Ludlum meter surveys for line clearance after both the assay (OPSRAD SOP09-02) and loading operations (OPSRAD SOP09-03) to ensure that no sources had been left behind. A final inspection (OPSRAD SOP09-04), performed by the Biocompatibles Quality Department, verified that the magazine plunger heights on the four (4) full magazines were identical, indicating fifteen (15) sources per magazine. After all of these quality control measures took place, all sixty (60) sources were sent to the Hospital. Biocompatibles delivered a sterile Applicator Kit (Case 75152), containing four (4) Mick magazines of fifteen (15) sources each, for a total of sixty (60) sources, to the Hospital on February 25, 2013. The lot number for the I-125 sealed sources was Lot 2013-24638. When first notified by the Hospital on February 26, 2013 of the possible issue, the Biocompatibles Radiation Lab performed additional meter surveys. Biocompatibles performs production station surveys at the completion of each production operation, and performs meter surveys of the entire facility at shift end. All surveys performed on February 26, 2013 through March 13, 2013 have not identified any misplaced seeds. The empty Supplier vial and pig used to deliver the sources to Biocompatibles was shipped to the Hospital with the case in question. Biocompatibles has requested all empty packing associated with the case to be returned to Biocompatibles for further investigation. Notified R1DO (Trapp) and R4DO (Werner). ILTAB and FSME Events Resource notified via e-mail. 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 |
| Where | |
|---|---|
| Biocompatibles Inc. Oxford, Connecticut (NRC Region 1) | |
| License number: | 06-30764-02MD |
| Organization: | Biocompatibles Inc. |
| Reporting | |
| 10 CFR 20.2201(a)(1)(ii) | |
| Time - Person (Reporting Time:+506.75 h21.115 days <br />3.016 weeks <br />0.694 months <br />) | |
| Opened: | Wayne Richardson 14:45 Mar 19, 2013 |
| NRC Officer: | Mark Abramovitz |
| Last Updated: | Mar 20, 2013 |
| 48831 - NRC Website | |
Biocompatibles Inc. with 10 CFR 20.2201(a)(1)(ii) | |
WEEKMONTHYEARENS 488312013-02-26T13:00:00026 February 2013 13:00:00
[Table view]10 CFR 20.2201(a)(1)(ii) Potential Loss of Brachytherapy Seeds 2013-02-26T13:00:00 | |