BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOGLYCOLLATE CULTURE MEDIA

    MDR report key: 17315 · Received November 1, 1994

    Report

    Report Number
    MW1003854
    Event Type
    Malfunction
    Date Received
    November 1, 1994
    Date of Event
    October 18, 1994
    Report Date
    October 25, 1994
    Manufacturer
    PML MICROBIOLOGICALS
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 10/18/94 MICRO PERSONNEL NOTED THAT SOME UNINOCULATED THIOGLYCOLLATE BROTHS (THIOS) WERE GROWING MOLDS. SEVERAL PTS' CULTURES GREW OUT MOLDS ALSO. INVESTIGATION OF THIOS SHOWS MOLD GROWING ON LABELS AND SHIPPING CARTONS. INVESTIGATION OF POSITIVE CULTURES SHOWS NO MOLD ISOLATED ON REPEAT CULTURES (WHEN POSSIBLE) OR THAT THE PTS' CLINICAL PRESENTATION DOES NOT IMPLICATE A FUNGAL INFECTION. ALL THIOS OF IMPLICATED LOTS WERE DISCARDED 10/25/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THOGLYCOLLATE CULTURE MEDIA CULTURE MEDIA JSC PML MICROBIOLOGICALS 081601T, 081602T, 081701T

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other