BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 17293711 · Received July 10, 2023

    Report

    Report Number
    1119779-2023-00757
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    July 3, 2023
    Report Date
    November 5, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZI
    UDI-DI
    10382902212635
    PMA / PMN Number
    PREAMENDMENT
    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: DURING MANUFACTURING OF MATERIAL 221263, MEDIA IS FORMULATED AND SENT THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN. THE PETRI DISHES ARE SUBJECTED TO UV RADIATION TO DECREASE BIOBURDEN. THE PETRI DISHES ARE FILLED IN A POSITIVE PRESSURE HEPA FILTERED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED INTO SLEEVES TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVES ARE THEN PACKAGED INTO CARTONS AND THEN TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE DISTRIBUTOR. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD REVIEW FOR BATCH 3143424 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO PRODUCT SPECIFICATIONS. ALL PHYSICAL ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES THERE WERE 7 PHOTOS AVAILABLE FOR REVIEW TO ASSIST WITH THIS COMPLAINT. THE FIRST PHOTO SHOWS A ROW OF 6 STACKS OF SLEEVED PLATES. THE FIRST TWO SLEEVES DO NOT HAVE A LABEL VISIBLE, THE LAST FOUR SLEEVES HAVE A VISIBLE SLEEVE LABEL. THE VIEWABLE LABELS INDICATE MATERIAL 221263, LOT 3143424, AND EXPIRATION 2023¿9-25. THE SECOND PHOTO SHOWS A CLOSE UP OF THE SLEEVE LABEL FOR MATERIAL 221263, LOT 3143424, AND EXPIRATION 2023-09-25. THE THIRD PHOTO SHOWS A STACK OF PLATES WITH THE SLEEVE ON AND SLEEVE LABEL PRESENT. THE FOURTH PHOTO SHOWS THE STOP OF 5 STACKS OF PLATES. THERE ARE NO SLEEVE LABELS VISIBLE IN THIS PHOTO. HE REMAINING THREE PHOTOS APPEAR TO BE DUPLICATES OF PHOTOS 2, 3, AND 4. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE PHOTOS PROVIDED. NO COMPLAINT TREND HAS BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SLEEVES OF BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD WERE MISSING LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT 2 SLEEVES ARE MISSING LABELS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SLEEVES OF BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD WERE MISSING LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT 2 SLEEVES ARE MISSING LABELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314493 BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ENRICHED KZI BECTON, DICKINSON & CO. (SPARKS) 221263 UNKNOWN 10382902212635

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown