ENS 57935: Difference between revisions

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| NRC officer = Josue Ramirez
| NRC officer = Josue Ramirez
| event date = 09/08/2025 00:00 CDT
| event date = 09/08/2025 00:00 CDT
| last update date = 09/17/2025
| last update date = 10/29/2025
| title = Contamination Detected in Shipping Vial
| title = Contamination Detected in Shipping Vial
| event text = The following information was provided by the Illinois Emergency Management Agency (the Agency) via email: "The Agency was contacted on September 8, 2025, by Bard Brachytherapy in Carol Stream, Illinois, to advise that they had detected contamination in a shipment of (72) TheraSeed Model 200 Pd-103 brachytherapy seeds. This is the second shipment of brachytherapy seeds since August, 2025, in which contamination was identified. The first occurrence identified contamination within the shipping vial and no leaking seeds. That occurrence failed to meet reportable criteria. Both shipments had been received directly from the manufacturer, Theragenics, in Georgia. The contamination did not result in any public or occupational exposures, nor were the licensee's facilities contaminated. However, based on additional information provided on September 11, 2025, this matter is reportable to the Agency under 32 Ill. Adm. Code 340.1230(a)(3)(A), the State's equivalent of 10 CFR 20.2203(a)(3)(i). The seeds have been returned to the manufacturer for investigation and to determine if a seed was leaking or there is a repeat instance of a contaminated shipping vial. "Details: The shipment consisted of (72) sources at 1.55 millicuries each, for a total consignment of 267.3 millicuries. The brachytherapy seeds are TheraSeed model 200's, under registry number NR-0645-S-101-S. Upon receipt and transfer of brachytherapy seeds to a sterile area, the Illinois licensee surveys the empty shipping vial. It is in this step they identified contamination, later quantified to be approximately 0.013 microcuries. The reportability stems from the fact their license requires testing for contamination prior to incorporating the sources into an implanting device. The reporting threshold is 0.005 microcuries, and thus, this represented the presence of contamination in a restricted area breaching an applicable limit in the license. It is noteworthy a previous incident reported to the Agency on August 21, 2025, also found contamination in a shipping vial, although it did not exceed 0.005 microcuries. The Georgia program was contacted and notified of the incident as well. The licensee met applicable reporting timelines. This report will be updated with any additional information provided by the manufacturer."  Item Number: IL250039
| event text = The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:
| URL = https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2025/20250925en.html#en57935
The Agency was contacted on September 8, 2025, by Bard Brachytherapy in Carol Stream, Illinois, to advise that they had detected contamination in a shipment of (72) TheraSeed Model 200 Pd-103 brachytherapy seeds. This is the second shipment of brachytherapy seeds since August, 2025, in which contamination was identified. The first occurrence identified contamination within the shipping vial and no leaking seeds. That occurrence failed to meet reportable criteria. Both shipments had been received directly from the manufacturer, Theragenics, in Georgia. The contamination did not result in any public or occupational exposures, nor were the licensee's facilities contaminated. However, based on additional information provided on September 11, 2025, this matter is reportable to the Agency under 32 Ill. Adm. Code 340.1230(a)(3)(A), the State's equivalent of 10 CFR 20.2203(a)(3)(i). The seeds have been returned to the manufacturer for investigation and to determine if a seed was leaking or there is a repeat instance of a contaminated shipping vial.
Details: The shipment consisted of (72) sources at 1.55 millicuries each, for a total consignment of 267.3 millicuries. The brachytherapy seeds are TheraSeed model 200's, under registry number NR-0645-S-101-S. Upon receipt and transfer of brachytherapy seeds to a sterile area, the Illinois licensee surveys the empty shipping vial. It is in this step they identified contamination, later quantified to be approximately 0.013 microcuries. The reportability stems from the fact their license requires testing for contamination prior to incorporating the sources into an implanting device. The reporting threshold is 0.005 microcuries, and thus, this represented the presence of contamination in a restricted area breaching an applicable limit in the license. It is noteworthy a previous incident reported to the Agency on August 21, 2025, also found contamination in a shipping vial, although it did not exceed 0.005 microcuries. The Georgia program was contacted and notified of the incident as well. The licensee met applicable reporting timelines. This report will be updated with any additional information provided by the manufacturer.
Item Number: IL250039
* * * UPDATE ON OCTOBER 29, 2025, AT 0811 EDT FROM KIM STICE TO KAREN COTTON * * *
The following information was provided by the Illinois Emergency Management Agency and Office of Homeland Security via email:
Update: On 10/21/25, Bard received investigation results from Theragenics which did not confirm if the sources were determined to have been leaking but did state that they concluded that the likely root cause for the contaminated vials was from insufficiencies in the production process. Theragenics also stated their intent to improve the 'transferring of seeds' and 'additional seed swipes' steps in their process. Retraining of staff on seed swiping and visual inspection was also to be conducted.
This matter may be considered closed pending additional information.
Notified R3DO (Ziolkowski) and NMSS Events Notifications (email).
| URL = https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2025/20251030en.html#en57935
}}
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Latest revision as of 06:20, 30 October 2025

ENS 57935 +/-
Where
Bard Brachytherapy
Carol Stream, Illinois (NRC Region 3)
License number: IL-02062-01
Organization: Illinois Emergency Mgmt. Agency
Reporting
Agreement State
Time - Person (Reporting Time:+223.77 h9.324 days <br />1.332 weeks <br />0.307 months <br />)
Opened: Gary Forsee
12:46 Sep 17, 2025
NRC Officer: Josue Ramirez
Last Updated: Oct 29, 2025
57935 - NRC Website
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