BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESIUM-137 TUBE SOURCE

    MDR report key: 15529 · Received August 25, 1994

    Report

    Report Number
    MW1003185
    Event Type
    Malfunction
    Date Received
    August 25, 1994
    Date of Event
    June 1, 1994
    Report Date
    August 16, 1994
    Manufacturer
    AMERSHAM CORP.
    Product Code
    IWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    IT IS EXTREMELY DIFFICULT TO READ THE SERIAL NUMBERS ON THE TUBE SOURCES. THE ONLY WAY IS TO HOLD THEM VERY CLOSE, USING MAGNIFIERS. THIS RESULTS IN RADIATION DOSES TO THE EYE WHICH ARE EXCESSIVE. SINCE MFR IS CURRENTLY THE SOLE PROVIDER OF THESE SOURCES, THEY SHOULD BE COMPELLED TO MAKE THE SERIAL NUMBERS EASILY DISCERNABLE LIKE ANOTHER MFR'S WERE BEFORE THEY STOPPED MAKING THEM. THE US NRC REQUIRES THAT POSITIVE SOURCE ID BE MADE ROUTINELY, BEFORE AND AFTER EACH USE. THUS, PERSONNEL USING THE SOURCES ARE ROUTINELY EXPOSED TO HIGH DOSE RATES. ADDITIONALLY, THE BARELY-LEGIBLE SERIAL NUMBERS CAN EASILY BE CONFUSED, AND THE POTENTIAL FOR INSERTING A WRONGLY-IDENTIFIED SOURCE INTO A PT IS SIGNIFICANT. THE WHOLE PROBLEM CAN EASILY BE AVOIDED BY MARKING THE SOURCES WITH LARGER ID NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CESIUM-137 TUBE SOURCE CESIUM-137 TUBE SOURCE IWH AMERSHAM CORP. CDCTI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other