BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CO-57

    MDR report key: 3024758 · Received March 26, 2013

    Report

    Report Number
    3024758
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    August 1, 2012
    Report Date
    March 26, 2013
    Manufacturer
    ECKERT AND ZIEGLER ISOTOPE PRODUCTS
    Product Code
    IXD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123995 CO-57 SOURCE, CALIBRATION, SEALED, NUCLEAR IXD ECKERT AND ZIEGLER ISOTOPE PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *