BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 21979507 · Received May 7, 2025

    Report

    Report Number
    1119779-2025-00364
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 11, 2025
    Report Date
    June 30, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - MGIT PANTA IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED BY MACHINE. THE VIALS ARE LYOPHILIZED AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). MGIT 960 GROWTH SUPPLEMENT IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. 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 SOP. SIX MGIT PANTA VIALS ARE THEN MANUALLY PACKAGED WITH SIX MGIT GROWTH SUPPLEMENT VIALS TO MAKE A MGIT 960 SUPPLEMENT KIT (MATERIAL 245124). PANTA BATCH NUMBER 4221619 WAS PROVIDED BY THE PHOTOS RECEIVED. BATCH HISTORY REVIEW FOR PANTA BATCH 4221619 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE RETENTION SAMPLES FOR BATCH 4221619 WERE NOT AVAILABLE TO ASSIST WITH THIS INVESTIGATION. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE PHOTOS SHOWED ONE STOPPERED PANTA VIAL (BATCH 4221619 EXP 2026-02-11) WITH A MASS FLOATING IN THE MEDIA. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO BATCH NUMBER OF THE KIT BACTEC MGIT 960 SUPPLEMENT 100 TEST (245124) WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION FOR A DEFECT IN KIT BACTEC MGIT 960 SUPPLEMENT 100 TEST (MATERIAL 245124). THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION OF UNKNOWN KIT BATCH BASED ON THE PHOTOS PROVIDED. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR THIS DEFECT.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT THAT ONE (1) SUPPLEMENT VIAL EXHIBITED BIOLOGICAL CONTAMINATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT THAT ONE (1) SUPPLEMENT VIAL EXHIBITED BIOLOGICAL CONTAMINATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128443 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) UNKNOWN 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown