ENS 58011
ENS Event | |
|---|---|
05:00 Oct 21, 2025 | |
| Title | ≪Br≫≪Br≫ |
| Event Description | AGREEMENT STATE REPORT - POTENTIAL OVEREXPOSURE
The following is a summary of information provided by the Arkansas Department of Health (the Department) via email: During a routine inspection on October 21, 2025, the Department was made aware that on two separate occasions, the production manager had performed repairs on the production line of F-18 fluorodeoxyglucose (FDG) without wearing dosimetry. On Tuesday, October 28, 2025, inspectors from the Department were following up on the concerns and confirmed that on one occasion, the production manager was not wearing dosimetry during the replacement of tubing on a cracked line inside a production hot cell. This repair was conducted along a 25.4 cm (10 inches) tubing line with one end being 10 cm (3.9 inches) from the source vial of F-18. The activity of the source was 118.4 GBq (3.2 Ci) as per the radiation safety officer (RSO). Re-enactment of the procedure was produced with the production manager to reconstruct similar parameters. The RSO initially was not made aware of the individual not wearing dosimetry. Dose estimation is currently being conducted by the RSO and by the Department. The licensee will also have an independent contractor perform a dose calculation for the event that was conducted without dosimetry. While dose estimations are being calculated, the Department believes it has enough information to determine that this event threatens to cause an extremity exposure greater than or equal to 250 rads, and thus, are reporting immediately to the NRC in accordance with SA-300. This investigation is ongoing and updates will be provided. Arkansas Event Number: ARK-2025-014
The following information was provided by the Arkansas Department of Health (the Department) via email: A written report has been provided to the Department on November 4th, 2025, from the radiation safety officer (RSO) of the licensee regarding the investigated incidents. The Department is performing dose calculations to compare using measurements and information gathered from the investigation. The Department's time-motion study of the unbadged repair procedure by the product manager has reduced the time of exposure significantly. Due to the shortening of time, this incident is more than likely not going to exceed the reporting threshold of an extremity exposure greater than or equal to 250 rads. The Department will continue to provide updates and comparison of dose estimation. Important of note, there is a third incident mentioned by the RSO that occurred involving the same product manager that is referenced as the 'resin pack event'. This event occurred on October 23, between our routine inspection on October 21, 2025, and our investigation which occurred on October 28, 2025. This event was not a part of the allegation but was discussed in detail during the investigation. The written report was submitted from Arkansas Licensee, ARK-1008-03124 and this report will be submitted to the NMED database." Notified R4DO (Vossmar), NMSS Events Notifications (email).
The following information was provided by the Arkansas Department of Health (the Department) via email and phone: Dose calculations have been performed by the RSO of the facility and the Department. For dose calculations, even with simplification of geometry by using a point source estimate, the largest estimate calculated was 7.1 rads. The section chief requested consideration of the geometry of the source vial along with tubing and spill, which better fits the modeling of the exposure. This brought the calculations to around 2.7 rads. The RSO estimates a dose of approximately 1 rad. Our estimates compared to the RSO of 3DI's estimate were comparable and do not exceed the dosage reporting requirement of an extremity of 250 rads. The Department has determined that this event is not reportable to the NRC. The written report is still on the stage of corrective actions and is undergoing conversations between the RSO and the department. The Department's intention to submit the final investigation report to the NRC regardless, as it has drawn attention. Notified R4DO (Agrawal), NMSS Events Notifications (email). |
| Where | |
|---|---|
| 3D Imaging Drug Design Development Little Rock, Arkansas (NRC Region 4) | |
| License number: | ARK-1008-03214 |
| Organization: | Arkansas Department Of Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+180.68 h7.528 days <br />1.075 weeks <br />0.247 months <br />) | |
| Opened: | Hunter Broadway 17:41 Oct 28, 2025 |
| NRC Officer: | Kerby Scales |
| Last Updated: | Dec 17, 2025 |
| 58011 - NRC Website | |
3D Imaging Drug Design Development with Agreement State | |
WEEKMONTHYEARENS 580112025-10-21T05:00:00021 October 2025 05:00:00
[Table view]Agreement State ≪Br≫≪Br≫ ENS 566262023-07-07T05:00:0007 July 2023 05:00:00 Agreement State Lost Package ENS 554652021-06-16T05:00:00016 June 2021 05:00:00 Agreement State Missing Radioactive Shipment 2025-10-21T05:00:00 | |