BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MGIT¿ OADC ENRICHMENT

    MDR report key: 19303386 · Received May 13, 2024

    Report

    Report Number
    1119779-2024-00376
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 15, 2024
    Report Date
    October 28, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382902451168
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. G.5. PMA / 510(K)#: K954932, K974883 H.3. 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 WAS REVIEWED AND WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED AND THERE ARE NO OTHER COMPLAINTS ON THIS BATCH. RETENTION SAMPLES FROM BATCH 2343383 WERE EXPIRED AND NOT AVAILABLE FOR INSPECTION. THERE WERE NO PHOTOS SUBMITTED NOR RETURNS RECEIVED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BBL¿ MGIT¿ OADC ENRICHMENT, BOTTLE CONTAMINATION WAS PRESENT WHICH LED TO A CONTROL SAMPLE GROWING MICROBACTERIUM TESTACEUM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BBL¿ MGIT¿ OADC ENRICHMENT, BOTTLE CONTAMINATION WAS PRESENT WHICH LED TO A CONTROL SAMPLE GROWING MICROBACTERIUM TESTACEUM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663045 BD BBL¿ MGIT¿ OADC ENRICHMENT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 2343383 30382902451168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown