BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MGIT¿ OADC

    MDR report key: 22135586 · Received June 3, 2025

    Report

    Report Number
    1119779-2025-00534
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 12, 2025
    Report Date
    July 16, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382902451168
    PMA / PMN Number
    K954932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA/510(K)#: K974883. 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 - BACTEC MGIT OADC ENRICHMENT (MATERIAL 245116) IS MANUFACTURED BY MIXING MEDIA COMPONENTS INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED AND DISPENSED INTO VIALS; STOPPERS ARE MANUALLY PLACED IN THE VIAL OPENING; SEPTUM CAPS ARE MANUALLY PLACED ON TOP OF THE STOPPER AND THEN MECHANICALLY CRIMPED PER STANDARD OPERATING PROCEDURE. SIX BACTEC MGIT OADC ENRICHMENT VIALS ARE THEN MANUALLY PACKAGED INTO A CARTON TO COMPLETE THE KIT. THE BATCH HISTORY RECORD FOR MGIT 960 GROWTH SUPPLEMENT BATCH 4284940 WAS SATISFACTORY PER INTERNAL PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED AND THERE ARE NO OTHER COMPLAINTS ON BATCH 4284940. FOR THIS PRODUCT, RETENTION SAMPLES ARE MAINTAINED AS INDIVIDUAL COMPONENTS AND NOT TESTED AS THE PHOTOS CAN CONFIRM THE COMPLAINT DEFECT. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THIS COMPLAINT. BOTH PHOTOS SHOWED SUPPLEMENT VIAL BATCH 4284940 EXP 2026-04-10 WITH A WHITE MASS FLOATING IN THE MEDIA. NO RETURNS WERE RECEIVED TO ASSIST WITH THIS COMPLAINT INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION FROM THE PHOTOS RECEIVED. NO COMPLAINT TRENDS WERE IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING BD BBL¿ MGIT¿ OADC, ONE (1) SEALED OADC VIAL WAS OBSERVED TO HAVE FUNGAL CONTAMINATION. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING BD BBL¿ MGIT¿ OADC, ONE (1) SEALED OADC VIAL WAS OBSERVED TO HAVE FUNGAL CONTAMINATION. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889553 BD BBL¿ MGIT¿ OADC SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4284940 30382902451168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown