BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15204042 · Received August 10, 2022

    Report

    Report Number
    1119779-2022-01091
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 14, 2022
    Report Date
    March 20, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE.

    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 2131414 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 2131414. RETENTION SAMPLES FROM BATCH 2131414 WERE NOT AVAILABLE FOR INSPECTION. FORTY PLATES FROM BATCH 2131414 WERE RETURNED AS FOUR UNOPENED SLEEVES SHIPPED IN A BOX WITH PAPER PADDING. PLATES WERE INSPECTED AND 5/40 PLATES HAD SURFACE BACTERIAL GROWTH (TIME STAMPS 1413, 1434-1436, 1441, 1446). ONE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. THREE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE AGAR SURFACE OF TWO OPENED PLATES WITH BACTERIAL GROWTH. ANOTHER PHOTO FEATURES A CARTON LABEL FROM BATCH 2131414 (CARTON 0707) FOR BATCH VERIFICATION. THE LAST PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 2131414 (TIME STAMP 1446) WITH GROWTH VISIBLE IN THE PLATE. THIS COMPLAINT CAN BE CONFIRMED. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THERE WAS CONTAMINATED / DISCOLORED MEDIA. THE FOLLOWING WAS REPORTED: " CUSTOMER REPORTS 30 BOXES OF MEDIA 221261 WITH LOT#: 2131414 AFFECTED WITH BIOLOGICAL CONTAMINATION AND DISCOLORATION OF AGAR. CUSTOMER REPORTS THE ISSUE IS PRESENT ALL ACROSS 30 BOXES OF THE PRODUCT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THERE WAS CONTAMINATED / DISCOLORED MEDIA. THE FOLLOWING WAS REPORTED: " CUSTOMER REPORTS 30 BOXES OF MEDIA (B)(6) WITH LOT#: 2131414 AFFECTED WITH BIOLOGICAL CONTAMINATION AND DISCOLORATION OF AGAR. CUSTOMER REPORTS THE ISSUE IS PRESENT ALL ACROSS 30 BOXES OF THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133464 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2131414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown