BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 23524443 · Received November 11, 2025

    Report

    Report Number
    1119779-2025-05233
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 25, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902973547
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - MATERIAL 297354 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 5093464 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING OR INSPECTION. FORMULATION, FILLING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS ARE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND THERE ARE NO COMPLAINT TRENDS ON BATCH 5093464. RETENTION SAMPLE INSPECTION WAS PERFORMED; ONE LOOSE CAP AND NO BROKEN TUBES WERE OBSERVED. THERE WAS ONE PHOTO SUBMITTED FOR REVIEW OF THIS INVESTIGATION, WHICH SHOWED A TUBE WITH THE CAP AND CAP AREA OF THE TUBE BROKEN FROM THE TUBE. THIS COMPLAINT CAN BE CONFIRMED FOR BROKEN TUBE AND LOOSE CAP. NO COMPLIANT TREND HAS BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR BROKEN TUBE AND LOOSE CAP DEFECTS.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ TRYPTICASE¿ SOY BROTH, THE TUBE BROKE IN THE USER'S HAND, WHEN THEY WERE TIGHTENING THE CAP. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ TRYPTICASE¿ SOY BROTH, THE TUBE BROKE IN THE USER'S HAND, WHEN THEY WERE TIGHTENING THE CAP. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645900 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) 5093464 30382902973547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown