BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16595670 · Received March 22, 2023

    Report

    Report Number
    1119779-2023-00323
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    March 6, 2023
    Report Date
    May 4, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 3011495 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE AND BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL PHYSICAL ATTRIBUTE AND 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 3011495. RETENTION SAMPLES FROM BATCH 3011495 WERE NOT AVAILABLE FOR INSPECTION. SIX PHOTOS WERE RECEIVED FOR INVESTIGATION. ALL SIX PHOTOS EACH SHOW THE AGAR SURFACE OF AN OPENED PLATE WITH WHAT APPEARS TO BE DRIED SURFACE MOISTURE. NO CONTAMINATION WAS OBSERVED IN THE PHOTOS. NO PLATE PRINTS OR PRODUCT LABELS ARE VISIBLE IN THE PHOTO FOR BATCH VERIFICATION. WITHOUT BATCH VERIFICATION, THE PHOTOS CANNOT CONFIRM THE COMPLAINT. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL. 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 WHILE USING THE BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE DID NOT INOCULATE THE CONTAMINATED MEDIA. BACTERIA OR FUNGI CONTAMINATION ¿ COLONY COLOR? THE COLONIES WERE WHITE IN COLOR AND GAVE THE APPEARANCE OF A BACTERIAL CONTAMINATION, NOT FUNGAL. LOCATION OF CONTAMINATION ¿ SURFACE OR SUB-SURFACE. THE COLONIES WERE LOCATED ON THE SURFACE. THE TIME STAMP IS UNAVAILABLE. BOTH PACKS WERE LOT #3011495 AND HAD A MIDDLE OF APRIL EXPIRATION DATE. ALL OF THE PRODUCT RECEIVED WAS CONTAMINATED. QUANTITY RECEIVED AND QUANTITY AFFECTED: 2 OF 2 BOXES. CUSTOMER REPORTING CONTAMINATION FOR PRODUCT 221261 LOT NO. 3011495.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE DID NOT INOCULATE THE CONTAMINATED MEDIA. BACTERIA OR FUNGI CONTAMINATION, COLONY COLOR?: THE COLONIES WERE WHITE IN COLOR AND GAVE THE APPEARANCE OF A BACTERIAL CONTAMINATION, NOT FUNGAL. LOCATION OF CONTAMINATION, SURFACE OR SUB-SURFACE: THE COLONIES WERE LOCATED ON THE SURFACE. THE TIME STAMP IS UNAVAILABLE. BOTH PACKS WERE LOT #3011495 AND HAD A MIDDLE OF APRIL EXPIRATION DATE. ALL OF THE PRODUCT RECEIVED WAS CONTAMINATED. QUANTITY RECEIVED AND QUANTITY AFFECTED: 2 OF 2 BOXES CUSTOMER REPORTING CONTAMINATION FOR PRODUCT 221261 LOT NO. 3011495.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10666 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) SEE H.10 JSG BECTON, DICKINSON & CO. (SPARKS) 3011495

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown