BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN

    MDR report key: 22574441 · Received July 23, 2025

    Report

    Report Number
    1119779-2025-01789
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    May 30, 2023
    Report Date
    July 2, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217887
    PMA / PMN Number
    K803023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT CAN BE CONFIRMED BY THE TREND. THE COMPLAINT HISTORY WAS REVIEWED, AND TWO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 3011172 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO CONTAMINATION OR TURBIDITY WAS OBSERVED IN 10/10 RETENTION SAMPLES. FOR INVESTIGATION, TWO RETENTION TUBES WENT INTO INCUBATION. ONE TUBE WAS INCUBATED IN THE 20-25 DEGREES CELSIUS, AND THE OTHER TUBE WAS PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR. AT 7 DAYS INCUBATION, NO MICROBIAL GROWTH OR TURBIDITY WAS OBSERVED IN 2/2 INCUBATED TUBES. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION. THE PHOTO SHOWS TWO TUBES, ONE FROM BATCH 3011172 AND ONE TUBE FROM BATCH 2251073. THE TUBE FROM BATCH 3011172 DOES APPEAR TO BE HAZY IN CLARITY. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE CAUSE OF THE HAZY MEDIA IN THE PHOTO COULD NOT BE IDENTIFIED FROM THIS INVESTIGATION. HOWEVER, BD HAS IDENTIFIED A COMPLAINT TREND FOR HAZY MEDIA DUE TO THE PRESENCE OF NON-VIABLES FOR THIS PRODUCT. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED PER BD PROCEDURES. THE CAPA HAS COMPLETED EXECUTION OF CORRECTIVE ACTIONS. BD EXPECTS IMPROVEMENT IN THE OBSERVATION OF HAZY MEDIA DUE TO NON-VIABLES AS THE CAPA PROGRESSES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION/APPEARANCE (TURBIDITY) DEFECTS. THIS COMPLAINT CAN BE CONFIRMED BY THE TREND. "THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, A TUBE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785389 BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 3011172 30382902217887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown