BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR

    MDR report key: 22747980 · Received August 8, 2025

    Report

    Report Number
    1119779-2025-02741
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 19, 2023
    Report Date
    July 3, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902217340
    PMA / PMN Number
    K803025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 MEDICAL DEVICE LOT #: 3161027 WAS REPORTED, HOWEVER, THIS IS NOT A LOT NUMBER MANUFACTURED FOR THE REPORTED CATALOG NUMBER. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, H4. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: THE BATCH NUMBER PROVIDED FOR INVESTIGATION WAS 3161027. MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO RECORD OF BATCH 3161027 MADE OF MATERIAL 221734. AN EXPIRATION DATE OF 2023-07-25 WAS PROVIDED. FROM REVIEW OF BATCHES OF MATERIAL 221734 IT APPEARS THAT SUBJECT BATCH FOR THIS INVESTIGATION IS 3101027. THE BATCH HISTORY RECORD FOR BATCH 3101027 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INVESTIGATION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. AFFECTED PRODUCT DOES NOT HAVE ANY STERILITY CLAIMS; THE PRODUCT IS TESTED FOR BIOBURDEN PRIOR TO RELEASE TO ENSURE THAT IT CONFORMS TO PRODUCT SPECIFICATIONS. HOWEVER, THIS DOES NOT ENSURE THAT THE END-USER WILL NOT RECEIVE A CONTAMINATED PLATE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 3101027. RETENTION SAMPLES FROM BATCH 3101027 WERE NOT AVAILABLE FOR INSPECTION. ONE PHOTO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS THE AGAR SURFACE OF EIGHT PLATES WITH GROWTH. NO PLATE PRINT OR PRODUCT LABELS ARE VISIBLE IN THE PHOTO FOR BATCH VERIFICATION. WITHOUT BATCH VERIFICATION, THE PHOTO CANNOT CONFIRM THE COMPLAINT. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR, MEDIA WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223788 BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 3161027 10382902217340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown