BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)

    MDR report key: 19234713 · Received May 2, 2024

    Report

    Report Number
    1119779-2024-00337
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 5, 2024
    Report Date
    December 27, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    00382902212836
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY DURING MANUFACTURING OF MATERIAL 221283, 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 4032739 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED CORRECT FORMULATION, AND ALL MANUFACTURING PROCESSES WERE WITHIN SPECIFICATIONS. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. TRYPTICASE SOY AGAR IS STABILITY TESTED BIENNIALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 4032739 FOR PH VARIANCE. THIS COMPLAINT WAS ALSO NOT CONFIRMED. NO RETENTION SAMPLES WERE AVAILABLE FOR INSPECTION. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) THAT THE PH OF THE MEDIA WAS LOWER THAN THE VALUE PROVIDED IN THE CERTIFICATE OF ANALYSIS. THE CUSTOMER OBTAINED A PH RESULT OF 5.8 INSTEAD OF THE ANTICIPATED PH OF 7.3. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) THAT THE PH OF THE MEDIA WAS LOWER THAN THE VALUE PROVIDED IN THE CERTIFICATE OF ANALYSIS. THE CUSTOMER OBTAINED A PH RESULT OF 5.8 INSTEAD OF THE ANTICIPATED PH OF 7.3. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858660 BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) 4032739 00382902212836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown