BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL BRAIN HEART INFUSION AGAR DEEP FILL

    MDR report key: 11281829 · Received February 4, 2021

    Report

    Report Number
    1111096-2021-00002
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    January 13, 2021
    Report Date
    March 30, 2021
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KZI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : DURING MANUFACTURING OF MATERIAL 221569, MEDIA IS FORMULATED USING THE DEHYDRATED CULTURE MEDIA (DCM) WITH USP PURIFIED WATER. MEDIA IS THEN PROCESSED THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN AND IS ASEPTICALLY DISPENSED DIRECTLY INTO PETRI DISHES. THE PETRI DISHES ARE THEN SEALED INTO CLEAN SLEEVES AND BOXED. PERSONNEL WORKING IN THE FILLING AREA ARE REQUIRED TO WEAR FULL BODY JUMPSUITS, HOODS, BOOTS, MASKS AND GLOVES. DISPENSING AND SLEEVING ARE COMPLETED WITHIN ISO CERTIFIED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVE ARE 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 FOR BATCH 0310231 WAS SATISFACTORY AT TIME OF RELEASE AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. 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 OUR 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 TYPICAL LEVELS. 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 THIS BATCH FOR CONTAMINATION. NINE PLATES FROM BATCH 0310231 WERE RETURNED AS ONE PARTIAL, OPENED SLEEVE IN THE 10PACK CARTON SHIPPED IN A BOX WITH PAPER PADDING AND BUBBLE WRAP. PLATES WERE INSPECTED, AND NO MICROBIAL GROWTH WAS OBSERVED ON 9/9 PLATES RETURNED AT INITIAL INSPECTION (TIME STAMP 1903). NO PHYSICAL DEFECTS WERE OBSERVED IN THE RETURNED PLATES. FOR INVESTIGATION OF THIS COMPLAINT, RETURNED PLATES WERE INCUBATED AT 20 TO 25 DEGREES C (4 PLATES) AND 33 TO 37 DEGREES C (5 PLATES). NO MICROBIAL GROWTH OR CHANGES WERE OBSERVED IN 9/9 RETURN PLATES AT 3 DAYS INCUBATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ BRAIN HEART INFUSION AGAR DEEP FILL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A FALSE POSITIVE MAY LEAD TO TREATMENT WITH A LESS TOLERATED ANTIBIOTIC WHICH CAN LEAD TO SERIOUS ADVERSE PATIENT CONSEQUENCE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ BRAIN HEART INFUSION AGAR DEEP FILL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A FALSE POSITIVE MAY LEAD TO TREATMENT WITH A LESS TOLERATED ANTIBIOTIC WHICH CAN LEAD TO SERIOUS ADVERSE PATIENT CONSEQUENCE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178855 BD BBL BRAIN HEART INFUSION AGAR DEEP FILL CULTURE MEDIA, ENRICHED KZI BECTON, DICKINSON & CO. 0310231

    Patients

    Seq Age Sex Outcome Treatment
    1