BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX)

    MDR report key: 11672189 · Received April 15, 2021

    Report

    Report Number
    1119779-2021-00671
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 23, 2021
    Report Date
    September 23, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 0365656 WAS SATISFACTORY AT TIME OF RELEASE AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. CHOCOLATE II AGAR IS STABILITY TESTED ANNUALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 0365656. RETENTION SAMPLES FROM BATCH 0365656 WERE NOT AVAILABLE FOR INSPECTION. FIVE PHOTOS WERE RECEIVED FOR INVESTIGATION. TWO PHOTOS ARE FOR COMPLAINT (B)(4); WITH EACH PHOTO SHOWING BOTTOM OF FOUR PLATES WITH GROWTH, TWO ARE FROM MACCONKEY AGAR BATCH 0358311 (TIME STAMP 2026) OR BATCH 0365665 (TIME STAMP 1254) WITH FOR COMPLAINT (B)(4). THE OTHER PLATES IN THOSE TWO PHOTOS ALSO HAVE GROWTH AND COMPARING EXPECTED GROWTH AND REACTIONS TO WHAT WAS OBTAINED ON BD BATCH 0358311 AND 0365665 PLATES. THE OTHER THREE PHOTOS EACH SHOW THE AGAR SURFACE OF TWO CHOCOLATE BROWN AGAR PLATES. IT IS DESCRIBED THAT EACH PHOTO SHOWS THE SURFACE OF PLATES WITH THE SAME INOCULUM THAT HAVE BEEN INCUBATED. IN EACH PHOTO, ONE PLATE HAS VISIBLY LESS GROWTH THAN THE OTHER AND THAT PLATE WITH LESS GROWTH IS DESCRIBED AS A PLATE FROM THE BATCH IN QUESTION. NO PLATE PRINTS OR PRODUCT LABELS FROM BATCH 0365656 ARE VISIBLE IN THE PHOTOS FOR BATCH VERIFICATION. IT IS FOLLOWED THAT THE PHOTOS ARE SHOWING THAT BD AGAR PLATES HAVE LESS GROWTH AS COMPARED TO THE OTHER MEDIA USED. HOWEVER, THIS INVESTIGATION CANNOT MAKE CONCLUSIONS ABOUT PERFORMANCE FROM PHOTOS ALONE. RETURN SAMPLES WERE NOT RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 4 BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS STATING THE BD AGAR PLATES HAVE POOR GROWTH ON THEM WHEN COMPARED TO ANOTHER UN NAMED BRAND OF PLATES THEY ARE USING. THIS WAS THE FIRST TIME THEY ORDERED THIS BD AGAR. THEY DID NOT RUN QC ON THE PLATES OR VALIDATION STUDIES. NO PLATES OF THIS LOT NUMBER REMAIN FOR CUSTOMER TO RUN QC OR VALIDATION AS THEY HAVE USED THE REMAINDER OF THE LOT. THEY ARE NOT CLAIMING THERE WERE ERRONEOUS RESULTS OR PATIENT TREATMENT WAS CHANGED DUE TO THIS ISSUE THEY ARE CLAIMING. THE PHOTOS PROVIDED BY THE CUSTOMER ARE COMPARING GROWTH ON BD PLATES TO GROWTH ON ANOTHER BRAND OF AGAR PLATES THEY WOULD NOT DISCLOSE THE BRAND OF. ALL ORGANISM THEY CLAIM ARE SHOWING POOR GROWTH ARE WILDTYPE SPECIMENS OBTAINED FROM PATIENT SAMPLES. THEY DID NOT TEST ANY ATCC STRAINS ON THE MEDIA."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 4 BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS STATING THE BD AGAR PLATES HAVE POOR GROWTH ON THEM WHEN COMPARED TO ANOTHER UN NAMED BRAND OF PLATES THEY ARE USING. THIS WAS THE FIRST TIME THEY ORDERED THIS BD AGAR. THEY DID NOT RUN QC ON THE PLATES OR VALIDATION STUDIES. NO PLATES OF THIS LOT NUMBER REMAIN FOR CUSTOMER TO RUN QC OR VALIDATION AS THEY HAVE USED THE REMAINDER OF THE LOT. THEY ARE NOT CLAIMING THERE WERE ERRONEOUS RESULTS OR PATIENT TREATMENT WAS CHANGED DUE TO THIS ISSUE THEY ARE CLAIMING. THE PHOTOS PROVIDED BY THE CUSTOMER ARE COMPARING GROWTH ON BD PLATES TO GROWTH ON ANOTHER BRAND OF AGAR PLATES THEY WOULD NOT DISCLOSE THE BRAND OF. ALL ORGANISM THEY CLAIM ARE SHOWING POOR GROWTH ARE WILDTYPE SPECIMENS OBTAINED FROM PATIENT SAMPLES. THEY DID NOT TEST ANY ATCC STRAINS ON THE MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573626 CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX) CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA JTY BECTON, DICKINSON & CO. (SPARKS) 221267 0365656 10382902212673

    Patients

    Seq Age Sex Outcome Treatment
    1