BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 24501002 · Received March 3, 2026

    Report

    Report Number
    1119779-2026-00283
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    September 11, 2025
    Report Date
    April 6, 2026
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    K003062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - MGIT 960 SIRE SUPPLEMENT IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXING 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 STANDARD OPERATING PROCEDURES (SOP). THE BATCH HISTORY RECORD REVIEWS FOR MGIT 960 SIRE KIT BATCH 5064051, MGIT 960 SIRE SUPPLEMENT BATCH 5024222, MGIT 960 STREPTOMYCIN BATCH 4207860, MGIT 960 ISONIAZID BATCH 4340755, MGIT 960 RIFAMPIN BATCH 4340757, AND MGIT 960 ETHAMBUTOL BATCH 4207864 WERE SATISFACTORY WITH NO QUALITY NOTIFICATIONS GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, AND LYOPHILIZATION PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING, INCLUDING ALL STERILITY AND ANTIBIOTIC SUSCEPTIBILITY TESTING, WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED; A TREND HAS BEEN IDENTIFIED FOR THIS DEFECT. THERE ARE NO PHOTOS OR RETURNED SAMPLES AVAILABLE TO ASSIST WITH THIS INVESTIGATION. RETENTION SAMPLES WERE NOT AVAILABLE FOR MGIT 960 SIRE SUPPLEMENT BATCH 5024222, MGIT 960 ISONIAZID BATCH 4340755, AND MGIT 960 RIFAMPIN BATCH 4340757. MGIT 960 STREPTOMYCIN BATCH 4207860 AND MGIT 960 ETHAMBUTOL BATCH 4207864 WERE AVAILABLE AND RECONSTITUTED WITH STERILE WATER. ONE VIAL EACH OF MGIT 960 STREPTOMYCIN BATCH 4207860 AND MGIT 960 ETHAMBUTOL BATCH 4207864 WERE INCUBATED AT 20¿25°C AND 33¿37°C. AT 14 DAYS, NO GROWTH WAS OBSERVED. THIS COMPLAINT CAN BE CONFIRMED. A CONTAMINATION TREND, WHICH INCLUDES THIS PRODUCT, HAS BEEN IDENTIFIED BY BD. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN OPENED TO FORMALLY INVESTIGATE THE ISSUE. THE CAPA IS CURRENTLY IN THE INVESTIGATION PHASE, AND BD WILL CONTINUE TO MONITOR AND TREND ALL CONTAMINATION RELATED COMPLAINTS.

    Additional Manufacturer Narrative · 0

    THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA/510(K)#: K014123. 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 WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) PATIENT SAMPLE WAS FOUND TO BE CONTAMINATED WITH BACTERIA IDENTIFIED AS BRADIRHIZOBIUM DENITRIFICANS. THE PATIENT TESTING WAS REPEATED AND THERE WAS NO HEALTH IMPACT REPORTED. THIS IS REPORT 6 OF 6.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) PATIENT SAMPLE WAS FOUND TO BE CONTAMINATED WITH BACTERIA IDENTIFIED AS BRADIRHIZOBIUM DENITRIFICANS. THE PATIENT TESTING WAS REPEATED AND THERE WAS NO HEALTH IMPACT REPORTED. THIS IS REPORT 6 OF 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205680 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 5064051 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown