BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11896804 · Received May 27, 2021

    Report

    Report Number
    1119779-2021-00910
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 29, 2021
    Report Date
    October 8, 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
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1007791. D4: MEDICAL DEVICE EXPIRATION DATE: 2021-04-20 . H4: DEVICE MANUFACTURE DATE: 2021-01-07. 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 BATCHES 1007791 AND 1021761 WERE SATISFACTORY AT TIME OF RELEASE AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION OF EITHER BATCH. 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 THESE BATCHES WERE 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 ONE OTHER COMPLAINT WAS TAKEN ON BATCH 1007791 FOR CONTAMINATION. NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1007791 FOR APPEARANCE AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1021761. RETENTION SAMPLES FROM BATCHES 1007791 AND 1021761 WERE NOT AVAILABLE FOR INSPECTION. RETURNS WERE RECEIVED FOR INVESTIGATION. ONE PLATE FROM BATCH 1007791 AND THREE PLATE FROM BATCH 1021761 IN A A ZIPLOCK BAG WERE RETURNED IN A FEDEX OVERPAK ENVELOPE. THE PLATE FROM BATCH 1007791 RETURNED HAD GROWTH ON THE TSA WITH 5% SHEEP BLOOD AGAR AND THERE WERE AGAR PARTICLES OBSERVED IN THE TSA WITH 5% SB AGAR (TIME STAMP 0943). THE AGAR PARTICLES COULD MAKE THE MEDIA APPEAR DISCOLORED AS THE CUSTOMER DESCRIBED. THE RETURNED PLATE FROM BATCH 1007791 WAS SUBMITTED TO THE ID LAB AND MICROCOCCUS LUTEUS WAS IDENTIFIED. THE THREE PLATES FROM BATCH 1021761 RETURNED HAD HEMOLYSIS IN THE TSA WITH 5% SB AGAR IN 2/3 PLATES AND 1/3 PLATES ALSO HAD A MIXTURE OF MEDIA IN THE TSA WITH 5% SB HALF OF THE BI-PLATE (TIME STAMPS 1207, 1209 AND 1232). THE MIXTURE OF MEDIA, CALLED MEDIA SPLASH OVER, IS A FILLING DEFECT WHERE AT LEAST ONE BI-PLATE HALVES CONTAINS A MIXTURE OF MEDIA. BOTH THE HEMOLYSIS AND MEDIA SPLASH OVER OBSERVED CAN CONTRIBUTE TO AN APPEARANCE OF DISCOLORATION. NO CONTAMINATION WAS OBSERVED IN THE RETURN PLATES FROM BATCH 1021761. NO PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION IN BATCH 1021761. THIS COMPLAINT CAN BE CONFIRMED FOR DISCOLORATION IN BATCH 1021761 AND CONTAMINATION AND DISCOLORATION IN BATCH 1007791. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION AND AGAR DEFECTS. DUE TO 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 WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " I BELIEVE 3 HAD DISCOLORATION AND 1 HAD CONTAMINATION. REPORTED CONTAMINATION AND/OR DISCOLORATION"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " I BELIEVE 3 HAD DISCOLORATION AND 1 HAD CONTAMINATION. REPORTED CONTAMINATION AND/OR DISCOLORATION"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790250 BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221291 SEE H10 10382902212918

    Patients

    Seq Age Sex Outcome Treatment
    1