BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CHOCOLATE II AGAR 100 EA

    MDR report key: 12729621 · Received November 1, 2021

    Report

    Report Number
    2243072-2021-02649
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 7, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JSG
    PMA / PMN Number
    K760459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 251267-MOLD, LOT#1152019. THE COMPLAINT WAS CONFIRMED AS THE REPORTED DEFECT ON A RETURNED SAMPLE. THE ISSUE WAS CONTAMINATION. NO ISSUE IN DEVICE HISTORY RECORD. NO ISSUE IN RETENTION SAMPLE. NO TREND BD QUALITY WILL CONTINUE TO MONITOR FOR TREND. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FUKUSHIMA. THIS SITE IS AN OEM MANUFACTURING SITE. (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 CHOCOLATE AGAR CATALOG NUMBER 221802 WHICH HAS 510K NUMBER K760459.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PLATE CHOCOLATE II AGAR 100 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: "THE CUSTOMER FOUND MOLD IN THE UNUSED MEDIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1626840 PLATE CHOCOLATE II AGAR 100 EA CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON 1152019

    Patients

    Seq Age Sex Outcome Treatment
    1