BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASE MEDICAL INSTRUMENT CANISTER

    MDR report key: 1293917 · Received January 16, 2009

    Report

    Report Number
    MW5009681
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    January 15, 2009
    Report Date
    January 16, 2009
    Manufacturer
    CASE MEDICAL
    Product Code
    FRG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT CANISTERS FROM CASE MEDICAL MULTIPLE LOT NUMBERS. RETENTION FILTER PLATES THAT HOLD FILTER IN PLACE IN CANISTERS SPINS FREELY. WE ARE QUESTIONING THE STERILITY OF THE PANS AND THE INSTRUMENTS. THE COMPANY HAS BEEN BROUGHT IN TO INSPECT THE PANS AND THE RETENTION FILTER PLATES AND THE REPS FROM THE COMPANY WERE ALARMED AT THE FREQUENCY OF SPINNING ON THE FILTER RETENTION PLATES. WE TESTED THE SPINNING ON NEW LIDS GIVEN TO US BY THE COMPANY AND WE CONTINUED TO FIND SPINNING OF THE FILTER RETENTION PLATES. STAFF TRIED TO WORK WITH COMPANY REPS WITH NO CHANGE IN SEVERITY OF PROBLEM. WE ARE QUESTIONING THE STERILITY OF THE INSTRUMENTS WHICH ARE PLACED IN THESE CANISTERS FOR REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASE MEDICAL INSTRUMENT CANISTER NONE FRG CASE MEDICAL SC-RING MUTLIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1