BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11649255 · Received April 12, 2021

    Report

    Report Number
    1119779-2021-00646
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 22, 2021
    Report Date
    September 27, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    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 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 BATCHES 1025854 AND 1021846 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 ON EITHER BATCH 1025854 OR BATCH 1021846. RETENTION SAMPLES FROM BATCHES 1025854 AND 1021846 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE SURFACE OF FOUR PLATES WITH ONE OR TWO MICROBIAL COLONIES ON EACH PLATE. THE OTHER PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1021846 (TIME STAMP 0616) WITH MICROBIAL GROWTH IN THE PLATE. NO PLATES FROM BATCH 1025854 WERE SHOWN IN THE PHOTOS. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT CAN BE CONFIRMED FOR BATCH 1021846 FOR CONTAMINATION. THE COMPLAINT CANNOT BE CONFIRMED FOR 1025854 FOR CONTAMINATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. BASED ON THE LOW DEFECT RATE FOR BATCH 1021846, NO ACTIONS ARE PLANNED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) BACTERIAL CONTAMINATION WAS DISCOVERED ON 5 PLATES FOR EACH LOT #. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION ON 221261 LOTS 1025854 AND 1021846. LOT: 1025854 - 5 PLATES AFFECTED OF 300 PLATES RECEIVED. LOT: 1021846 - 5 PLATES AFFECTED OF 200 PLATES RECEIVED. CUSTOMER REPORTS CONTAMINATION IS BACTERIAL AND APPEARS TO BE A STAPHYLOCCUS BASED ON APPEARANCE.

    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 #: 1025854. MEDICAL DEVICE EXPIRATION DATE: 2021-05-12. DEVICE MANUFACTURE DATE: 2021-01-25. 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 WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) BACTERIAL CONTAMINATION WAS DISCOVERED ON 5 PLATES FOR EACH LOT #. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION ON 221261 LOTS 1025854 AND 1021846. LOT: 1025854 - 5 PLATES AFFECTED OF 300 PLATES RECEIVED. LOT: 1021846 - 5 PLATES AFFECTED OF 200 PLATES RECEIVED. CUSTOMER REPORTS CONTAMINATION IS BACTERIAL AND APPEARS TO BE A STAPHYLOCCUS BASED ON APPEARANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544804 BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1021846

    Patients

    Seq Age Sex Outcome Treatment
    1