ENS Event | |
|---|---|
05:00 Nov 2, 2013 | |
| Title | Agreement State Report- Receiver Survey of Licensee-Shipped Package Detected Surface Contamination |
| Event Description | The following was received via email:
On 11/8/13, a licensee shipper informed this Agency [MA Radiation Control Program] that on 11/2/13 the licensee receiver survey of a package containing one patient dose of Fluorine-18 (F-18), indicated removable surface contamination exceeding 49 CFR 173.443 levels. The receiver notified the shipper on 11/2/13. The shipper reviewed the outgoing package survey, as well as routine facility and personnel surveys for 11/2/13, and determined there were no contamination issues. Transports are made via courier vehicles. The shipper retrieved the empty subject package on 11/4/13 during a normal delivery run. F-18 has a half-life of less than two hours. The receiver did use the contained dose for patient administration as intended on 11/2/13. On 11/8/13, this Agency attempted to contact the receiver to confirm specific contamination results obtained by the receiver's package survey. The licensee receiver has not yet responded to this Agency's inquiry so specific results are not yet known at the time of this report. The Agency considers this matter to be OPEN pending results of ongoing Agency investigation.
11/14/13 information from the receiver confirmed exclusive use shipment was used. With the new information, the Agency [Massachusetts Radiation Control Program] determined this is not a reportable event because 49 CFR 173.443 contamination limits to be applied should be ten times higher than limits applied previously. The receiver's removable contamination survey results no longer exceed limits. Notified R1DO (Bower) and FSME Events Resource via email. |
| Where | |
|---|---|
| Tba Molecular North America, Inc. Haverhill, Massachusetts (NRC Region 1) | |
| License number: | 41-0618 |
| Organization: | Ma Radiation Control Program |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+151.72 h6.322 days <br />0.903 weeks <br />0.208 months <br />) | |
| Opened: | Tony Carpenito 13:43 Nov 8, 2013 |
| NRC Officer: | Daniel Mills |
| Last Updated: | Nov 18, 2013 |
| 49520 - NRC Website | |
Tba Molecular North America, Inc. with Agreement State | |
WEEKMONTHYEARENS 495202013-11-02T05:00:0002 November 2013 05:00:00
[Table view]Agreement State Agreement State Report- Receiver Survey of Licensee-Shipped Package Detected Surface Contamination 2013-11-02T05:00:00 | |