BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ VITAMIN K1 - HEMIN SOLUTION

    MDR report key: 22953157 · Received September 3, 2025

    Report

    Report Number
    1119779-2025-04892
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    July 3, 2024
    Report Date
    July 10, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    PPM
    UDI-DI
    00382902123545
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL 212354 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 FOR BATCHES 3207657 OR 4060093 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH (B)(4). AT THE TIME OF THE COMPLAINT INVESTIGATION, BATCHES 3207657 (EXP 2024-01-23) AND 4060093 (EXP 2024-08-20) WERE BOTH EXPIRED AND RETENTION SAMPLES WERE UNABLE TO BE TESTED AS PART OF THE INVESTIGATION. NO RETURNS OR PHOTOS WERE PROVIDED FOR INVESTIGATION. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 212354 AND THERE ARE NO TRENDS IN ANY BATCH OVER THE LAST 12 MONTHS. BD WILL CONTINUE TO TREND FOR THIS ISSUE. THIS COMPLAINT CANNOT BE CONFIRMED. 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¿ VITAMIN K1 - HEMIN SOLUTION IN A RESEARCH STUDY ON HEALTHY PATIENT VOLUNTEERS, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED PERFORMANCE ISSUES WITH A DECREASE IN THE BACTERIA RICHNESS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474292 BD BBL¿ VITAMIN K1 - HEMIN SOLUTION GENERAL PURPOSE REAGENT PPM BECTON DICKINSON & CO. (SPARKS) 4060093 00382902123545

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown