BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11649151 · Received April 12, 2021

    Report

    Report Number
    1119779-2021-00645
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 12, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902212918
    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: 2021-03-17. H6: INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221291, 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 0345628 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 TWO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 0345628 FOR CONTAMINATION. NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 0345628 FOR HEMOLYSIS OR MISSING AGAR. RETENTION SAMPLES FROM BATCH 0345628 WERE NOT AVAILABLE FOR INSPECTION. RETURNS WERE RECEIVED FOR INVESTIGATION. EIGHTY PLATES FROM BATCH 0345628 WERE RETURNED AS EIGHT SLEEVES (1 OPENED AND 7 UNOPENED) SHIPPED IN A BOX WITH FOAM PADDING AND AIR BUBBLES (TIME STAMPS 0910, 0911, 0915, 0931, 1007-1009). BACTERIAL GROWTH WAS OBSERVED IN BOTH MEDIA OF 13/80 RETURNED PLATES. ONE RETURNED PLATE WITH GROWTH WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. IT IS NOTED THAT THE ONLY HEMOLYSIS SEEN IN THE RETURN SAMPLES ALSO HAVE GROWTH IN THE TSA WITH 5% SHEEP BLOOD MEDIA. NO PLATES WITH NO FILL OF THE BI-PLATE OR MISSING MEDIA WERE SEEN IN THE RETURNS. FOUR PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS A SLEEVE FROM BATCH 0345628 WITH ONE PLATE IN THE SLEEVE THAT APPEARS DARK BROWN-RED FROM HEMOLYSIS. TWO PHOTOS EACH SHOW AN OPENED PLATE FROM BATCH 0345628 (TIME STAMP NOT READABLE) WITH TSA WITH 5% SB AGAR THAT IS AT LEAST PARTIALLY TRANSLUCENT FROM WHAT COULD BE HEMOLYSIS NEXT TO A PLATE FROM BATCH 0345628 (TIME STAMP 0914) WITH TSA WITH 5% SB AGAR THAT IS OPAQUE AS EXPECTED. THE LAST PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 0345628 (TIME STAMP 0915) NEXT TO AN OPENED PLATE WITH GROWTH ON BOTH MEDIA. THIS COMPLAINT HAS BEEN CONFIRMED FOR HEMOLYSIS AND CONTAMINATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR MISSING AGAR BEDS. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE¿ SOY AGAR W 5% SHEEP BLOOD (TSA II) MACCONKEY II AGAR PLATES WERE DISCOVERED TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS CONTAMINATION.

    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 THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE¿ SOY AGAR W 5% SHEEP BLOOD (TSA II) MACCONKEY II AGAR PLATES WERE DISCOVERED TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544590 BD BBL TRYPTICASE SOY AGAR W 5% SHEEP BLOOD (TSA II) MACCONKEY II AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221291 0345628 10382902212918

    Patients

    Seq Age Sex Outcome Treatment
    1