BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17547453 · Received August 14, 2023

    Report

    Report Number
    1119779-2023-00886
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    August 8, 2023
    Report Date
    March 12, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE BATCH HISTORY RECORD FOR BATCH 3152962 WAS SATISFACTORY 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 BATCH 3152962. RETENTION SAMPLES FROM BATCH WERE NOT AVAILABLE FOR INSPECTION. TEN PLATES FROM BATCH 3152962 WERE RETURNED AS ONE UNOPENED SLEEVE SHIPPED IN A BOX WITH AIR BUBBLES. PLATES WERE INSPECTED AND 0/10 PLATES HAD MICROBIAL GROWTH (TIME STAMP 2001). FOR INVESTIGATION OF THIS COMPLAINT, RETURNED PLATES WERE INCUBATED AT 33 TO 37 DEGREES C. AT 3 DAYS INCUBATION, 0/10 PLATES HAD GROWTH. ONE PHOTO ALSO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS THE BOTTOM OF ONE PLATE FROM BATCH 3152962 (TIME STAMP 1957) WITH THE PLATE PRINT FEATURED FOR BATCH VERIFICATION AND THE AGAR SURFACE OF ANOTHER PLATE WITH A COLONY OF GROWTH. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION BY THE PHOTO PROVIDED. DUE TO THE LOW DEFECT RATE (1 PLATE REPORTED) FOR THIS BATCH; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CONTAMINATION ON PLATES OCCURRED. NO PATIENT IMPACT OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CONTAMINATED PLATE OF PRODUCT (B)(4). LOT NO. 3152962

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CONTAMINATION ON PLATES OCCURRED. NO PATIENT IMPACT OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CONTAMINATED PLATE OF PRODUCT 221261 LOT NO. 3152962.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246650 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 3152962

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown