BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿)

    MDR report key: 12045933 · Received June 22, 2021

    Report

    Report Number
    1119779-2021-01026
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 25, 2021
    Report Date
    November 24, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTY
    UDI-DI
    10382902212673
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DURING MANUFACTURING OF MATERIAL 221267, 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 FOR BATCH 1099147 WAS SATISFACTORY 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 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 1099147. RETENTION SAMPLES FROM BATCH 1099147 WERE NOT AVAILABLE FOR INSPECTION. NO RETURN SAMPLES OR PHOTOS WERE PROVIDED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. SEE H.10.

    Additional Manufacturer Narrative · 0

    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 PRIOR TO USE WITH BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) A PLATE WAS DISCOVERED TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTS CONTAMINATED PLATES FOR CAT 221267 LOT 1099147 - WHAT WAS THE CONDITION OF THE SHIPMENT UPON RECEIPT? NO ISSUES WERE SEEN UPON INITIAL RECEIPT. - HOW WAS THE PRODUCT STORED? REFRIGERANT 2-8C UPON ARRIVAL - DO YOU HAVE PHOTOS AVAILABLE SHOWING THE CONTAMINATION AND LOT NUMBER FOR EACH AFFECTED PRODUCT? NOT AT THIS TIME. - CAN YOU PLEASE CLARIFY THE TOTAL NUMBER OF BOXES RECEIVED FOR EACH PRODUCT? LOT: 1099147 NUMBER OF BOXES RECEIVED: 9 - DO YOU HAVE RETURNS AVAILABLE? NO - ARE YOU INTERESTED IN REPLACEMENT OR CREDIT? AT THIS TIME, VOLUME HAS NOT BEEN SIGNIFICANT FOR REPLACEMENT PRODUCT OR CREDIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) A PLATE WAS DISCOVERED TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTS CONTAMINATED PLATES FOR CAT 221267 LOT 1099147 WHAT WAS THE CONDITION OF THE SHIPMENT UPON RECEIPT? NO ISSUES WERE SEEN UPON INITIAL RECEIPT. HOW WAS THE PRODUCT STORED? REFRIGERANT 2-8C UPON ARRIVAL. DO YOU HAVE PHOTOS AVAILABLE SHOWING THE CONTAMINATION AND LOT NUMBER FOR EACH AFFECTED PRODUCT? NOT AT THIS TIME. CAN YOU PLEASE CLARIFY THE TOTAL NUMBER OF BOXES RECEIVED FOR EACH PRODUCT? LOT: 1099147 NUMBER OF BOXES RECEIVED: 9. DO YOU HAVE RETURNS AVAILABLE? NO. ARE YOU INTERESTED IN REPLACEMENT OR CREDIT? AT THIS TIME, VOLUME HAS NOT BEEN SIGNIFICANT FOR REPLACEMENT PRODUCT OR CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939141 BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA JTY BECTON, DICKINSON & CO. (SPARKS) 221267 1099147 10382902212673

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown