CO-57 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-26 for CO-57 * manufactured by Eckert And Ziegler Isotope Products.

Event Text Entries

[3326966] A plastic vial containing approximately 3 millicuries of solid cobalt 57 developed a leak. The leak was detected with a dry wipe test. The amount detected was extremely small, in a category that made the leakage non-reportable to the state or regulatory authorities. There was no contamination, no harm to patients or staff, and no spill. The vial did not appear to have any cracks or damage. Cobalt 57 is a solid epoxy matrix. The vial was not damaged during shipping. It had been in use at the hospital for almost a year. The physicist who performed the wipe test properly disposed of the cotton disk. The manufacturer was notified, the vial was returned to the manufacturer for disposal. The hospital received verification that they received the vial. The hospital obtained a replacement. The cause of the leakage is unknown. ======================manufacturer response for vial of cobalt radioisotope, unknown (per site reporter). ======================manufacturer notified the hospital that they received the vial for disposal. There was no warranty remaining and the hospital received a replacement. What was the original intended procedure? Not applicable.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3024758
• MDR Report Key: 3024758
• Date Received: 2013-03-26
• Date of Report: 2013-03-26
• Date of Event: 2012-08-01
• Report Date: 2013-03-26
• Date Reported to FDA: 2013-03-26
• Date Reported to Mfgr: 2013-03-28
• Date Added to Maude: 2013-03-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CO-57
• Generic Name: SOURCE, CALIBRATION, SEALED, NUCLEAR
• Product Code: IXD
• Date Received: 2013-03-26
• Returned To Mfg: 2012-08-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ECKERT AND ZIEGLER ISOTOPE PRODUCTS
• Manufacturer Address: 24937 AVENUE TIBBITTS VALENCIA CA 91355 US 91355

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-03-26