BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON II AGAR 20 EA

    MDR report key: 11495386 · Received March 16, 2021

    Report

    Report Number
    2243072-2021-00802
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 19, 2021
    Report Date
    March 12, 2021
    Manufacturer
    BECTON DICKINSON
    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. 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. 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 II AGAR CATALOG NUMBER 211438 WHICH IS A PREAMENDMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PLATE MUELLER HINTON II AGAR 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
    396195 PLATE MUELLER HINTON II AGAR 20 EA CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON DICKINSON 0316533

    Patients

    Seq Age Sex Outcome Treatment
    1