ENS 43700
ENS Event | |
|---|---|
05:00 Oct 4, 2007 | |
| Title | Agreement State Report - Molybdenum 99 Concentration Too High on Elution on Molybdenum 99/Technetium- 99M Generator |
| Event Description | The State provided the following information via email:
Event Cause: MOLYBDENUM 99 CONCENTRATION TOO HIGH ON ELUTION ON MOLYBDENUM 99/TECHNETIUM- 99M GENERATOR Event Date: 10/04/2007 Report Date: 10/05/2007 Licensee/Reporting Party Information: Name: PHARMACY SERVICES OF THE QUAD CITIES, License Number: 0207-1-82-NP, DAVENPORT, IA 52807 IDPH received a call from the Pharmacy Services of Quad Cities RSO on Friday, October 5, 2007, concerning a Bristol-Myers Squibb (BMS) Mo99/Tc99M generator that they had received on Wednesday, October 3, 2007. The licensee first eluted the generator on Thursday, October 4, 2007, and discovered an elevated Mo99 concentration in the elution. Subsequent elutions also had elevated Mo99 concentrations. The licensee contacted the manufacturer (BMS) and was asked to ship the generator back to the manufacturer. The licensee contacted IDPH concerning the shipping container. An Information Notice that was issued in 1997 talks to this issue, and IDPH told the licensee to hold the generator 10 1/2 lives or a special salvage container would be needed to ship the generator back to BMS. The State reported that elutions greater than .15 micro Curies per milli Curie Tc-99m are unacceptable and exceed establish limits. See Information Notice No. 84-85: 'Molybdenum Breakthrough From Technetium-99m Generators' Also a state representative said that the lot number of this generator was "M275711D," the size was 15 curies, the calibration date is 10/2 and the expiration date is 10/6. As of Monday October 8, 2007, the generator is being held at the pharmacy. Corrective Actions: Action Number: 1 MANUFACTURER WILL NOTIFY CUSTOMERS OF DEFECT Keywords: ELEVATED MO99 CONCENTRATION FROM GENERATOR ELUTION Source of Radiation: Source Number: 1 Form of Radioactive: ELEVATED MO99 CONCENTRATION Radionuclide or Voltage (kVp/MeV): MO-99 Source Use: RADIOPHARMACEUTICAL Manufacturer: BRISTOL-MEYERS SQUIB Device/Associated Equipment: Device Number: 1 Device Name: RADIOPHARMACEUTICAL GENERATOR Manufacturer: BRISTOL-MEYERS SQUIB Problem with Equipment: ELEVATED MO99 Reporting Requirements: 30.50(b)(2)(ii) - The 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> report of an event where required equipment is disabled or fails to function as designed when the equipment is required to be available and operable when it is disabled or fails to function. Iowa Event # IA070004
The manufacturer, Bristol-Meyers Squibb Medical Imaging Inc., reported back to the Iowa licensee number: IA-207-1-82-NP that it was indeterminate as to the cause of the problem. The State of Iowa considers this event closed. Notified R3DO (Duncan) and FSME (Burgess). |
| Where | |
|---|---|
| Pharmacy Services Of The Quad Cities Davenport, Iowa (NRC Region 3) | |
| License number: | 0207-1-82-NP |
| Organization: | Iowa Department Of Public Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+100.88 h4.203 days <br />0.6 weeks <br />0.138 months <br />) | |
| Opened: | Nancy Farmington 09:53 Oct 8, 2007 |
| NRC Officer: | Joe O'Hara |
| Last Updated: | Dec 18, 2007 |
| 43700 - NRC Website | |
Pharmacy Services Of The Quad Cities with Agreement State | |
WEEKMONTHYEARENS 437002007-10-04T05:00:0004 October 2007 05:00:00
[Table view]Agreement State Agreement State Report - Molybdenum 99 Concentration Too High on Elution on Molybdenum 99/Technetium- 99M Generator 2007-10-04T05:00:00 | |