BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSB GROWTH MEDIA 100 ML

    MDR report key: 397240 · Received May 28, 2002

    Report

    Report Number
    MW1025181
    Event Type
    Malfunction
    Date Received
    May 28, 2002
    Date of Event
    May 28, 2002
    Report Date
    May 28, 2002
    Manufacturer
    Q.I. MEDICAL, INC.
    Product Code
    JSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    USING Q.I. MEDICAL, INC, TSB GROWTH MEDIA, 100 ML, AS QA PROCESS VALIDATION TOOL. MEDIA WAS FOUND TO HAVE INANIMATE STERILE FILAMENTS FLOATING IN IT THAT INVALIDATE RESULTS OF TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSB GROWTH MEDIA 100 ML GROWTH MEDIA JSD Q.I. MEDICAL, INC. * 010076

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other