BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES

    MDR report key: 21809254 · Received April 9, 2025

    Report

    Report Number
    1119779-2025-00255
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 11, 2025
    Report Date
    June 23, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER ADDR 1: (B)(6). 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 - MATERIAL 245122 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 4200115 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING OR INSPECTION. FORMULATION, FILLING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS ARE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES WERE NOT INSPECTED DUE TO THE NATURE OF THIS COMPLAINT. THERE WERE SEVEN (7) PHOTOS SUBMITTED TO ASSIST WITH THIS COMPLAINT. THE PHOTOS SHOWS BATCH VERIFICATION FOR BATCH 4200115 WITH EXPIRATION 2026-01-14. THE TUBES IN THE PHOTOS SHOW BOTH BIOLOGICAL CONTAMINATION AND FOREIGN MATERIAL. THERE WERE NO RETURNS PROVIDED TO ASSIST WITH THIS INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, AN UNSPECIFIED NUMBER OF TUBES WERE OBSERVED TO HAVE TURBID CONTAMINATION. THE CUSTOMER ALSO NOTICED FOREIGN MATTER DESCRIBED AS A "BLACK UNIDENTIFIED OBJECT" FLOATING INSIDE TUBES. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, AN UNSPECIFIED NUMBER OF TUBES WERE OBSERVED TO HAVE TURBID CONTAMINATION. THE CUSTOMER ALSO NOTICED FOREIGN MATTER DESCRIBED AS A "BLACK UNIDENTIFIED OBJECT" FLOATING INSIDE TUBES. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664369 BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4200115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown