BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD

    MDR report key: 15157969 · Received August 3, 2022

    Report

    Report Number
    1119779-2022-01056
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 7, 2022
    Report Date
    August 31, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FUKUSHIMA, JAPAN. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, SPARKS HAS BEEN LISTED AND THE SPARKS FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY 251801 LOT#2073206 CONTAMINATION WE CONFIRMED THE ISSUE AS A REPORT FROM RETURNED SAMPLE. THE ISSUE WAS CONTAMINATION. NO TREND. WE WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD THE CUSTOMER NOTICED BIOLOGICAL CONTAMINATION . THIS EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FOUND FOREIGN MATTER WHICH COULD BE BACTERIA IN THE MEDIA."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD THE CUSTOMER NOTICED BIOLOGICAL CONTAMINATION . THIS EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FOUND FOREIGN MATTER WHICH COULD BE BACTERIA IN THE MEDIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903874 BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON, DICKINSON & CO. (SPARKS) 2073206

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown