BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC TESTER

    MDR report key: 57223 · Received December 19, 1996

    Report

    Report Number
    MW1010438
    Event Type
    Malfunction
    Date Received
    December 19, 1996
    Manufacturer
    MCGAW, INC.
    Product Code
    JTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FIVE OF THE FILTER/CULTURE CHAMBERS LEAKED WHEN CULTURE MEDIA WAS PUT IN THE CHAMBER. IN ALL CASES THE LEAK OCCURRED AT A CEMENTED SEAL USED TO JOIN THE DOME OF THE CHAMBER TO THE BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QC TESTER CULTURE MEDIA CHAMBER JTR MCGAW, INC. * E076

    Patients

    Seq Age Sex Outcome Treatment
    1 *