BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE SABOURAUD DEXTROSE AGAR

    MDR report key: 12628533 · Received October 13, 2021

    Report

    Report Number
    2243072-2021-02496
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 16, 2021
    Report Date
    September 22, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JSJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PLATE SABOURAUD DEXTROSE AGAR MOLD CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FOUND A BLACK SPOT RESEMBLING MOLD ON THE TOPMOST AGAR OF 10 DISHES BEFORE USAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527083 PLATE SABOURAUD DEXTROSE AGAR NA JSJ BECTON DICKINSON 1187357

    Patients

    Seq Age Sex Outcome Treatment
    1