BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12045921 · Received June 22, 2021

    Report

    Report Number
    1119779-2021-01024
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 26, 2021
    Report Date
    November 24, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 RECORDS FOR BATCHES 1077983 AND 1078183 WERE SATISFACTORY PER INTERNAL PROCEDURES. 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 1078183 AND THE ONLY OTHER COMPLAINT TAKEN ON BATCH 1077983 WAS ALSO FROM MAYO CLINIC FOR CONTAMINATION. RETENTION SAMPLES FROM BATCHES 1077983 AND 1078183 WERE NOT AVAILABLE FOR INSPECTION. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CONTAMINATION WAS DISCOVERED ON A PLATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) CUSTOMER REPORTS CONTAMINATED PLATES FOR CAT 221261 LOTS 1077983 AND 1078183. - 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: 1077983 NUMBER OF BOXES RECEIVED: 53. LOT: 1078183 NUMBER OF BOXES RECEIVED: 61

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CONTAMINATION WAS DISCOVERED ON A PLATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) CUSTOMER REPORTS CONTAMINATED PLATES FOR CAT 221261 LOTS 1077983 AND 1078183. - 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: 1077983 NUMBER OF BOXES RECEIVED: 53 LOT: 1078183 NUMBER OF BOXES RECEIVED: 61.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938726 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1078183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown