BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12648927 · Received October 18, 2021

    Report

    Report Number
    1119779-2021-01669
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 21, 2021
    Report Date
    August 12, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 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 1211108 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 1211108 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1211108 WERE NOT AVAILABLE FOR INSPECTION. SIX PHOTOS WERE RECEIVED FOR INVESTIGATION. --ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1211108 (TIME STAMP 1021) WITH THE PLATE PRINT FEATURED FOR BATCH VERIFICATION. --THREE PHOTOS EACH SHOW THE BOTTOM OF TWO PLATES FROM BATCH 1211108 (TIME STAMPS 1105, 1120 AND 1121) WITH WHAT COULD BE MICROBIAL GROWTH IN EACH PLATE. --ONE PHOTO SHOWS THE SIDE OF A STACK OF PLATES FROM BATCH 1211108 (TIME STAMPS 1021) WITH WHAT APPEARS TO BE MICROBIAL GROWTH IN ONE PLATE. --ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1211108 (TIME STAMP 1011) WITH MICROBIAL GROWTH VISIBLE. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 18 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) BACTERIAL CONTAMINATION WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING CONTAMINATION WITH PRODUCT 221261 LOT 1211108. *UPON VISUAL INSPECTION OF THE CONTAMINATED MEDIA WAS THE CONTAMINATION: -BACTERIA OR FUNGI? BACTERIA -ON THE SURFACE OR SUB-SURFACE? SURFACE IT WAS REPORTED THAT CONTAMINATION WITH 221261 PLATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 18 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) BACTERIAL CONTAMINATION WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING CONTAMINATION WITH PRODUCT 221261 LOT 1211108. UPON VISUAL INSPECTION OF THE CONTAMINATED MEDIA WAS THE CONTAMINATION: BACTERIA OR FUNGI? BACTERIA ON THE SURFACE OR SUB-SURFACE? SURFACE. IT WAS REPORTED THAT CONTAMINATION WITH 221261 PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547875 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1211108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown