BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11649477 · Received April 12, 2021

    Report

    Report Number
    1119779-2021-00647
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 22, 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
    NY, US
    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 RECORDS FOR BATCHES 1028365 AND 0329426 WERE 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 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 EITHER BATCH 1028365 OR BATCH 0329426. RETENTION SAMPLES FROM BATCHES 1028365 AND 0329426 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE AGAR SURFACE OF A PLATE WITH APPEARS TO BE A COLONY OF MICROBIAL GROWTH THAT HAS BEEN PICKED. THE OTHER PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1028365 (TIME STAMP 2049) WITH THE PLATE PRINT FEATURED FOR BATCH VERIFICATION. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT HAS BEEN CONFIRMED FOR BATCH 1028365. THIS COMPLAINT CANNOT BE CONFIRMED FOR BATCH 0329426. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. DUE TO THE LOW DEFECT RATE FOR BATCH 1028365, NO ACTIONS ARE PLANNED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    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¿) BACTERIAL CONTAMINATION WAS DISCOVERED. THIS OCCURRED WITH 10 PLATES OF LOT# 1028365 AND 30 WITH LOT# 0329426. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION IS BACTERIAL AND APPEARS TO BE A BACILLIUS BECAUSE OF A MUCOID APPEARANCE. LOT: 1028365 (B)(4). LOT: 0329426 (B)(4).

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1028365. MEDICAL DEVICE EXPIRATION DATE: 2021-05-25. DEVICE MANUFACTURE DATE: 2021-01-28. 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 · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿) BACTERIAL CONTAMINATION WAS DISCOVERED. THIS OCCURRED WITH 10 PLATES OF LOT# 1028365 AND 30 WITH LOT# 0329426. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION IS BACTERIAL AND APPEARS TO BE A BACILLIUS BECAUSE OF A MUCOID APPEARANCE. LOT: 1028365, 10 AFFECTED OF 100 RECEIVED. LOT: 0329426, 30 AFFECTED OF 200 RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545582 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 0329426 10382902212673

    Patients

    Seq Age Sex Outcome Treatment
    1