BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON II AGAR 20 EA

    MDR report key: 12193929 · Received July 19, 2021

    Report

    Report Number
    2243072-2021-01917
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 15, 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

    OEM MANUFACTURE: (B)(4). 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. INVESTIGATION SUMMARY: THE COMPLAINT WAS CONFIRMED AS THE REPORTED DEFECT ON A RETURNED SAMPLE. THE ISSUE WAS CONTAMINATION. NO ISSUE IN DHR. NO ISSUE IN RETENTION SAMPLE. ROOT CAUSE WAS UNDETERMINED. NO TREND. WE WILL CONTINUE TO MONITOR THE TREND THIS ISSUE.

    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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084443 PLATE MUELLER HINTON II AGAR 20 EA CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST JTZ BECTON DICKINSON 1095123

    Patients

    Seq Age Sex Outcome Treatment
    1