BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22885042 · Received August 25, 2025

    Report

    Report Number
    1119779-2025-04317
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    May 17, 2023
    Report Date
    June 30, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217429
    PMA / PMN Number
    K803023
    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

    D.3 COMMON DEVICE NAME: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL INVESTIGATION SUMMARY: MATERIAL 221742 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 2325733 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUING , AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. 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 ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 2325733. RETENTION SAMPLES FROM BATCH 2325733 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. TWO RETENTION TUBES WERE INCUBATED. ONE RETENTION TUBE WAS PLACED INTO 33-37-DEGREES CELSIUS INCUBATION, AND ONE RETENTION TUBE WAS PLACED INTO 20-25-DEGREES CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION PERIOD THERE WAS NO CHANGE IN THE MEDIA COLOR AND CLARITY AND THERE WAS NO MICROBIAL GROWTH OBSERVED IN 2/2 INCUBATED RETENTION TUBES. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. A SMALL SHIPPING BOX WAS RECEIVED WITH 15 INDIVIDUALLY BUBBLE WRAPPED TUBES. FIVE TUBES WERE FROM BATCH 3011171, FIVE TUBES WERE FROM BATCH 2279224, AND FIVE TUBES WERE FROM BATCH 2325733. THE COLOR AND CLARITY OF 5/5 RETURNED TUBES FROM BATCH 3011171 THE MEDIA WAS MEDIUM YELLOW AND HAZY. THE COLOR AND CLARITY FROM THE 5/5 RETURNED TUBES FROM BATCH 2279224 WAS MEDIUM YELLOW HAZY WITH TINY FINE PARTICLES. ALL 5/5 RETURNED TUBES FROM BATCH 2325733 THE MEDIA COLOR AND CLARITY WAS MEDIUM YELLOW AND TRACE HAZY AS DESCRIBE IN THE CERTIFICATE OF ANALYSIS. ALL 15/15 RETURNED TUBES WERE PLACED INTO 33-37-DEGREES CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION PERIOD THERE WAS NO CHANGE IN THE MEDIA COLOR AND CLARITY. ONE TUBE WAS PLATED ON TO TSA 5% SHEEP BLOOD AGAR FROM BATCH 3011171, 2279224, AND BATCH 2325733, AND NO ORGANISMS WERE RECOVERED. GRAM STAINS WERE ALSO PERFORMED ON BATCH 3011171, 2279224, AND BATCH 2279224. GRAM NEGATIVE RODS WERE OBSERVED FROM BATCH 3011171 AND BATCH 2279224, NO ORGANISMS WERE RECOVERED FROM BATCH 2325733. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION/APPEARANCE DEFECTS FROM BATCH 2325733 BASED ON THE EVIDENCE PROVIDED FROM THE RETURN SAMPLES RECEIVED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION/APPEARANCE/NON-VIABLES DEFECTS. BD HAS IDENTIFIED A COMPLAINT TREND FOR HAZY MEDIA DUE TO THE PRESENCE OF NON-VIABLES FOR THIS PRODUCT. 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 THAT WHILE USING THE BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, THERE WERE FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341775 BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN SEE H.11 JSG BECTON DICKINSON & CO. (SPARKS) 2325733 30382902217429

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown