BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MUELLER HINTON II AGAR

    MDR report key: 17760919 · Received September 15, 2023

    Report

    Report Number
    1119779-2023-01004
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 7, 2023
    Report Date
    March 13, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTZ
    UDI-DI
    10382902218002
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE BATCH HISTORY RECORD FOR 3115025 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS WHICH CAN BE OBTAINED AT (B)(6). (B)(6) IS STABILITY TESTED BIENNIALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 3115025. RETENTION SAMPLES FROM BATCH 3115025 WERE NOT AVAILABLE FOR INSPECTION. THREE PHOTOS WERE RECEIVED FOR INVESTIGATION. THE THREE PHOTOS EACH SHOW THE AGAR SURFACE OF AN OPENED PLATE WITH A LAWN OF GROWTH AND DISCS AND/OR STRIPS APPLIED. NO OBSERVATIONS ABOUT THE GROWTH CAN BE MADE FROM PHOTOS ALONE. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE DEFECTS.

    Additional Manufacturer Narrative · 0

    E.1 INITIAL REPORTER E-MAIL: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MUELLER HINTON II AGAR THAT THERE A PERFORMANCE ISSUE WITH GROWTH. THIS OCCURRED TO APPROXIMATELY 400 PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING THEY ARE NOT GETTING THE DENSE APPEARANCE ON THE AGAR. AFFECTED LOT NUMBER 3115025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MUELLER HINTON II AGAR THAT THERE A PERFORMANCE ISSUE WITH GROWTH. THIS OCCURRED TO APPROXIMATELY 400 PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING THEY ARE NOT GETTING THE DENSE APPEARANCE ON THE AGAR. AFFECTED LOT NUMBER 3115025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779072 BD BBL¿ MUELLER HINTON II AGAR CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON, DICKINSON & CO. (SPARKS) 3115025 10382902218002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown