BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11702302 · Received April 21, 2021

    Report

    Report Number
    1119779-2021-00693
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 24, 2021
    Report Date
    September 30, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-04-06. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221261, PLATE TRYPTICASE SOY AGAR 5% SB 100 EA FOR BATCH NUMBER 1042249 FOR CONTAMINATION. 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 1042249 WAS SATISFACTORY AT TIME OF RELEASE 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 1042249. RETENTION SAMPLES FROM BATCH 1042249 WERE NOT AVAILABLE FOR INSPECTION. ONE RETURN SAMPLE WAS RECEIVED FOR INVESTIGATION. ONE PARAFILMED PLATE FROM BATCH 1042249 (TIME STAMP 1445) WAS RETURNED IN A SMALL FEDEX BOX WITH BUBBLE WRAP. THE PLATE HAD A SURFACE BACTERIAL COLONY THAT APPEARED TO HAVE BEEN PICKED. THE PLATE WAS SUBMITTED TO THE ID LAB AND TSUKAMURELLA PAUROMETABOLA WAS IDENTIFIED. TWO PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. BOTH PHOTOS SHOW THE AGAR SURFACE OF A PLATE WITH A SURFACE BACTERIAL COLONY. THE COLONY DOES APPEAR TO HAVE BEEN PICKED LIKE WITH THE RETURNED PLATE. THIS COMPLAINT HAS BEEN CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME. THIS PRODUCT DOES NOT HAVE A STERILE CLAIM. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) GROWTH WAS DISCOVERED ON PLATE. GENETIC SEQUENCING CONDUCTED FOR INFORMATIONAL PURPOSES ONLY IDENTIFIED THE COLONY/GROWTH AS A SPECIES OF THE GENUS MICROBACTERIUM. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT GROWTH WAS OBSERVED ON ONE OF TWENTY PLATES TESTED. THE OBSERVED COLONY WAS OPAQUE AND YELLOW IN APPEARANCE, CIRCULAR, SMOOTH, WITH AN EVEN (ENTIRE) MARGIN, NO HEMOLYSIS WAS OBSERVED. GENETIC SEQUENCING CONDUCTED FOR INFORMATIONAL PURPOSES ONLY IDENTIFIED THE COLONY/GROWTH AS A SPECIES OF THE GENUS MICROBACTERIUM.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) GROWTH WAS DISCOVERED ON PLATE. GENETIC SEQUENCING CONDUCTED FOR INFORMATIONAL PURPOSES ONLY IDENTIFIED THE COLONY/GROWTH AS A SPECIES OF THE GENUS MICROBACTERIUM. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT GROWTH WAS OBSERVED ON ONE OF TWENTY PLATES TESTED. THE OBSERVED COLONY WAS OPAQUE AND YELLOW IN APPEARANCE, CIRCULAR, SMOOTH, WITH AN EVEN (ENTIRE) MARGIN, NO HEMOLYSIS WAS OBSERVED. GENETIC SEQUENCING CONDUCTED FOR INFORMATIONAL PURPOSES ONLY IDENTIFIED THE COLONY/GROWTH AS A SPECIES OF THE GENUS MICROBACTERIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599655 BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1042249

    Patients

    Seq Age Sex Outcome Treatment
    1