BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON AGAR 5% SB 20 EA

    MDR report key: 11558549 · Received March 23, 2021

    Report

    Report Number
    1119779-2021-00548
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 22, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTZ
    PMA / PMN Number
    PREAMENDMENT
    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. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ MUELLER HINTON AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221176 WHICH IS A PREAMENDMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 20 PLATE MUELLER HINTON AGAR 5% SB 20 EA CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447283 PLATE MUELLER HINTON AGAR 5% SB 20 EA CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON, DICKINSON & CO. (SPARKS) 0323741

    Patients

    Seq Age Sex Outcome Treatment
    1