BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

    MDR report key: 12052003 · Received June 23, 2021

    Report

    Report Number
    1119779-2021-01036
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 26, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    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

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221261, 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 1078571 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 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 THE ONLY OTHER COMPLAINT ON BATCH 1078571 WAS TAKEN FROM DUKE EYE CENTE. RETENTION SAMPLES FROM BATCH 1078571 WERE NOT AVAILABLE FOR INSPECTION. FOUR PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1078571 (TIME STAMP 1116) WITH THE PLATE PRINT FEATURED FOR BATCH VERIFICATION. ANOTHER PHOTO SHOWS THE AGAR SURFACE OF A MEDIUM RED AGAR PLATE WITH A FEW SMALL PITS VISIBLE AND A BACTERIAL COLONY GROWING . THE THIRD PHOTO SHOWS THE AGAR SURFACE OF A MEDIUM RED AGAR PLATE WITH PITS. THE LAST PHOTO SHOWS THE AGAR SURFACE OF A PLATE WITH TWO BACTERIAL COLONIES ON THE SURFACE. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT HAS BEEN CONFIRMED. NO TRENDS FOR CONTAMINATION OR PITS HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION AND PITS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) 6 PLATES WITH CONTAMINATION AND 13 PLATES WITH PHYSICAL DEFECTS WERE OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "6 PLATES ARRIVE WITH BACTERIAL CONTAMINATION. 13 PLATES EXHIBIT PITS/BUBBLES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) 6 PLATES WITH CONTAMINATION AND 13 PLATES WITH PHYSICAL DEFECTS WERE OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "6 PLATES ARRIVE WITH BACTERIAL CONTAMINATION. 13 PLATES EXHIBIT PITS/BUBBLES.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945607 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1078571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown