BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 23880444 · Received December 23, 2025

    Report

    Report Number
    1119779-2025-05532
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 3, 2025
    Report Date
    March 4, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BACTEC MGIT 960 SIRE KIT BATCH 5098017 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 5050800, MGIT 960 STREPTOMYCIN BATCH 5024123, MGIT 960 ISONIAZID BATCH 5024214, MGIT 960 RIFAMPIN BATCH 5024215, AND MGIT 960 ETHAMBUTOL BATCH 5024216. 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 STOPPERS, AND THE VIALS ARE 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 HOMOGENEOUS 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 BACTEC MGIT 960 SIRE KIT (MATERIAL 245123). THE BATCH HISTORY RECORD REVIEWS FOR COMPONENT LOTS, AS WELL AS FOR THE BACTEC MGIT 960 SIRE KIT BATCH 5098017, 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, WERE SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY HAS BEEN REVIEWED, AND NO COMPLAINT TRENDS WERE IDENTIFIED. RETENTION SAMPLES OF SUPPLEMENT BATCH 5050800, STREPTOMYCIN BATCH 5024123, ISONIAZID BATCH 5024214, RIFAMPIN BATCH 5024215, AND ETHAMBUTOL BATCH 5024216 WERE AVAILABLE FOR INSPECTION. TWO SUPPLEMENT VIALS WERE INCUBATED; ONE AT 20¿25°C AND ONE AT 33¿37°C FOR SEVEN DAYS. TWO VIALS OF EACH LYOPHILIZED DRUG WERE RECONSTITUTED; FOR EACH DRUG BATCH, ONE VIAL WAS INCUBATED AT 20¿25°C AND ONE VIAL AT 33¿37°C FOR SEVEN DAYS. AFTER SEVEN DAYS OF INCUBATION, VISUAL INSPECTION SHOWED NO CONTAMINATION IN ANY OF THE VIALS. THERE WERE NO PHOTOS OR RETURNED SAMPLES AVAILABLE TO ASSIST WITH THIS INVESTIGATION. BECAUSE THE CONTAMINATION DEFECT WAS NOT IDENTIFIED IN RETENTION SAMPLES, AND NO RETURNED SAMPLES OR PHOTOS DOCUMENTING CONTAMINATED SUPPLEMENT OR DRUG VIALS WERE AVAILABLE, THIS COMPLAINT COULD NOT BE CONFIRMED. NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE FOUND TO BE CONTAMINATED WITH BRADYRHIZOBIUM DENTRIFICANS UPON IDENTIFICATION FROM A DIFFERENT PUBLIC HEALTH LAB. THE CUSTOMER STATED THAT CONTAMINATION WAS VISUALLY OBSERVED IN THE ISONIAZID, ETHAMBUTOL, AND POSSIBLY RIFAMPIN TUBE SAMPLES. THE CONTAMINATION WAS NOTICED DUE TO UNUSUAL TURBIDITY IN THE AFFECTED TUBES. IT WAS ALSO NOTED THAT QC WAS AFFECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE FOUND TO BE CONTAMINATED WITH BRADYRHIZOBIUM DENTRIFICANS UPON IDENTIFICATION FROM A DIFFERENT PUBLIC HEALTH LAB. THE CUSTOMER STATED THAT CONTAMINATION WAS VISUALLY OBSERVED IN THE ISONIAZID, ETHAMBUTOL, AND POSSIBLY RIFAMPIN TUBE SAMPLES. THE CONTAMINATION WAS NOTICED DUE TO UNUSUAL TURBIDITY IN THE AFFECTED TUBES. IT WAS ALSO NOTED THAT QC WAS AFFECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829995 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 5098017 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown