BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 20530051 · Received October 24, 2024

    Report

    Report Number
    1119779-2024-00783
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    October 4, 2024
    Report Date
    March 10, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902210932
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: MATERIAL 221093 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED, AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCH 4123398 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 4123398 WERE NOT AVAILABLE FOR INSPECTION. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THAT GRAM-NEGATIVE BACILLI WERE OBSERVED IN A GRAM STAIN OF A CSF CULTURE AFTER 5 DAYS INCUBATION AT 35°C. THE END USER SUSPECTED CONTAMINATION AND PERFORMED A GRAM STAIN ON UNUSED SOY BROTH. GRAM-NEGATIVE BACILLI WERE OBSERVED IN AN UNSPECIFIED NUMBER OF TUBES. SUBCULTURE OF THE BROTH RESULTED IN NO GROWTH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THAT GRAM-NEGATIVE BACILLI WERE OBSERVED IN A GRAM STAIN OF A CSF CULTURE AFTER 5 DAYS INCUBATION AT 35°C. THE END USER SUSPECTED CONTAMINATION AND PERFORMED A GRAM STAIN ON UNUSED SOY BROTH. GRAM-NEGATIVE BACILLI WERE OBSERVED IN AN UNSPECIFIED NUMBER OF TUBES. SUBCULTURE OF THE BROTH RESULTED IN NO GROWTH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818584 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) 4123398 30382902210932

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown