BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13961148 · Received March 31, 2022

    Report

    Report Number
    1119779-2022-00484
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 2, 2022
    Report Date
    January 5, 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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221261, PLATE TRYPTICASE SOY AGAR 5% SB 100 EA, BATCH NUMBER 2033740 AND BD COMPLAINT NUMBER 4624864 FOR LABELING. 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 2033740 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL AND SLEEVE ATTRIBUTE TESTING. SAMPLE PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL AND SLEEVE ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO TYPICAL LEVELS. ALL PHYSICAL AND SLEEVE ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER OUR INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2033740. RETENTION SAMPLES FROM BATCH 2033740 WERE NOT AVAILABLE FOR INSPECTION. THIRTY PLATES FROM BATCH 2033740 WERE RETURNED AS THREE SLEEVES (2 UNOPENED, 1 OPENED) IN BOX WITH BUBBLE WRAP (TIME STAMPS 1551 AND 1552). A CARTON LABEL FROM BATCH 2033740 (CARTON NUMBER 0393) WAS ATTACHED TO THE OPENED SLEEVE; THERE WAS NOT A SLEEVE LABEL ON THE OPENED SLEEVE. FOR THE OTHER TWO UNOPENED SLEEVES RETURNED, ONE SLEEVE DID NOT HAVE A SLEEVE LABEL AND ONE SLEEVE HAD A LABEL THAT WAS TORN. TWO PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. EACH PHOTO SHOWS THREE SLEEVES, ONE WITH A TORN SLEEVE LABEL AND TWO WITHOUT SLEEVE LABELS, AND A CARTON LABEL FROM BATCH 2033740 FOR BATCH VERIFICATION. THIS PRODUCT IS PACKAGED INTO SLEEVES AND LABELED VIA AN AUTOMATED PROCESS. IF A FAILURE IN THE SLEEVE LABELING PROCESS OCCURS, EACH PLATE OF THIS PRODUCT IS LABELED SO THE MEDIA TYPE, BATCH AND EXPIRATION DATE ARE READILY AVAILABLE. THIS COMPLAINT CAN BE CONFIRMED FOR MISSING AND TORN SLEEVE LABELS. NO COMPLAINT TRENDS FOR LABELING HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 3 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) MISSING LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SLEEVES THAT ARE MISSING THE LABEL AND TORN LABEL FOR CAT 221261 LOT 2033740. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 3 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) MISSING LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SLEEVES THAT ARE MISSING THE LABEL AND TORN LABEL FOR CAT 221261 LOT 2033740. ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107209 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2033740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown