BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD

    MDR report key: 12729268 · Received November 1, 2021

    Report

    Report Number
    2243072-2021-02648
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 7, 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: 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 IN 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 AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221176 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. NO TREND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 10 BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD 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
    1626818 BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST JTZ BECTON DICKINSON 1152047

    Patients

    Seq Age Sex Outcome Treatment
    1