BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR

    MDR report key: 17856966 · Received October 2, 2023

    Report

    Report Number
    1119779-2023-01041
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 11, 2023
    Report Date
    April 23, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902217340
    PMA / PMN Number
    K803025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE BATCH HISTORY RECORD FOR BATCH 3200741 WAS SATISFACTORY PER INTERNAL PROCEDURES. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL AND SLEEVE ATTRIBUTE TESTING. SAMPLE PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL AND SLEEVE ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO TYPICAL LEVELS. ALL PHYSICAL AND SLEEVE ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 3200741 FOR LABELING DEFECTS. NO RETENTION SAMPLES FROM BATCH 3200741 WERE AVAILABLE FOR INSPECTION. THREE UNOPENED SLEEVES (30 PLATES) WERE RETURNED FOR INVESTIGATION OF THIS COMPLAINT. EACH SLEEVE HAD A SLEEVE LABEL, BUT THE INFORMATION IS NOT READABLE DUE TO LIGHT OR FADING PRINT (TIME STAMPS 0438 AND 0717). THREE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO FEATURES A SLEEVE LABEL FROM BATCH 3200741 WITH PRINT THAT IS SLIGHTLY FADED BUT STILL READABLE. ANOTHER PHOTO SHOWS FIVE SLEEVES WHERE ONE SLEEVE DOES NOT HAVE A LABEL, TWO SLEEVES APPEAR TO HAVE PRINT THAT IS FADED, AND TWO SLEEVES APPEAR TO HAVE INFORMATION MISSING FROM THE LABELS. THE LAST PHOTO SHOWS A SLEEVE LABEL WITH FADED PRINT THAT IS NOT LEGIBLE. THIS PRODUCT IS PACKAGED INTO SLEEVES AND LABELED VIA AN AUTOMATED PROCESS. IF A FAILURE IN THE SLEEVE LABELING PROCESS OCCURS, EACH PLATE OF THIS PRODUCT IS LABELED SO THE MEDIA TYPE, BATCH NUMBER AND EXPIRATION DATE ARE READILY AVAILABLE. THIS COMPLAINT CAN BE CONFIRMED FOR MISSING SLEEVE LABEL AND ILLEGIBLE SLEEVE LABELS. NO COMPLAINT TREND FOR LABELING DEFECTS HAS BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME PER BD PROCEDURES. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING DEFECTS.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR, THERE WERE 4 BOXES OF PLATES WITH MISSING LABELS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "4 BOXES OF PLATES 221734, LOT#: 3200741 WITH MISSING LABELS AND "GLUE" SMEAR ALL OVER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR, THERE WERE 4 BOXES OF PLATES WITH MISSING LABELS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "4 BOXES OF PLATES 221734, LOT#: 3200741 WITH MISSING LABELS AND "GLUE" SMEAR ALL OVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847036 BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) 3200741 10382902217340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown