BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 22937479 · Received September 2, 2025

    Report

    Report Number
    1119779-2025-04779
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 5, 2025
    Report Date
    November 13, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    K003062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MGIT 960 SIRE SUPPLEMENT KIT BATCH 3233725 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 3194553, MGIT 960 STREPTOMYCIN BATCH 3179118, MGIT 960 ISONIAZID BATCH 3179117, MGIT 960 RIFAMPIN BATCH 3179116, AND MGIT 960 ETHAMBUTOL BATCH 3179114. THE BATCH HISTORY RECORD REVIEWS FOR THE KIT AND EACH OF ITS COMPONENTS WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON ANY OF THE COMPONENTS. MGIT 960 SIRE 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 STANDARD OPERATING PROCEDURES (SOP). ANTIBIOTICS MGIT 960 STREPTOMYCIN, MGIT 960 ISONIAZID, MGIT 960 RIFAMPIN AND MGIT 960 ETHAMBUTOL ARE MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXING 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 SOP. EIGHT MGIT 960 SIRE SUPPLEMENT VIALS ARE THEN MANUALLY PACKAGED WITH ONE VIAL OF EACH ANTIBIOTIC TO MAKE A MGIT 960 SIRE SUPPLEMENT KIT (MATERIAL 245123). THE BATCH HISTORY RECORD REVIEW FOR BATCH 3233725 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING AND AUTOCLAVE PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON KIT BATCH 3233725 FOR PERFORMANCE OR CONTAMINATION. RETENTION SAMPLES FROM BATCH 3233725 WERE NOT AVAILABLE FOR INSPECTION. NO PHOTOS OR RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. IT IS NOTED THAT BATCH 3233725 EXPIRED ON 28-DEC-2024 AND THIS COMPLAINT WAS TAKEN ON 05-AUG-2025. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS. BD WILL CONTINUE TO TREND FOR PERFORMANCE AND CONTAMINATION. THIS COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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, AN UNKNOWN NUMBER OF RESISTANT PATIENT RESULTS TO ISONIAZID WERE OBTAINED. THE USER QUESTIONED THE RESULTS DUE TO OBSERVING THE ATCC25177 GROWTH CONTROL TUBE APPEARING "FLAKY" WITH NO VISIBLE GROWTH. NO CONFIRMATORY TESTING WAS PERFORMED; HOWEVER, THE USER STATED SUSCEPTIBLE RESULTS TO ISONIAZID WERE EXPECTED. THERE WERE NO KNOWN HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, AN UNKNOWN NUMBER OF RESISTANT PATIENT RESULTS TO ISONIAZID WERE OBTAINED. THE USER QUESTIONED THE RESULTS DUE TO OBSERVING THE (B)(6) GROWTH CONTROL TUBE APPEARING "FLAKY" WITH NO VISIBLE GROWTH. NO CONFIRMATORY TESTING WAS PERFORMED; HOWEVER, THE USER STATED SUSCEPTIBLE RESULTS TO ISONIAZID WERE EXPECTED. THERE WERE NO KNOWN HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246186 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 3233725 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown