BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 22061402 · Received May 21, 2025

    Report

    Report Number
    1119779-2025-00460
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 23, 2025
    Report Date
    June 17, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). 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 - MGIT 960 SIRE SUPPLEMENT KIT BATCH 4242482 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 4193147, MGIT 960 STREPTOMYCIN BATCH 4159881, MGIT 960 ISONIAZID BATCH 4159882, MGIT 960 RIFAMPIN BATCH 4159883, AND MGIT 960 ETHAMBUTOL BATCH 4159884. 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 THIS KIT BATCH OR 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). RETENTION SAMPLES FROM THE COMPONENTS FROM KIT BATCH 4242482 WERE AVAILABLE FOR INSPECTION. FOR THIS INVESTIGATION 12 RETENTION SAMPLES OF MGIT 960 SIRE SUPPLEMENT BATCH 4193147 WAS INSPECTED. NONE OF THE RETENTION SAMPLES CONTAINED CONTAMINATION OR FOREIGN MATTER. FOR FURTHER INVESTIGATION FOUR SIRE SUPPLEMENT VIALS WERE INCUBATED. TWO SUPPLEMENT VIAL CRIMP CAPS WERE REMOVED. ONE UNCRIMPED AND ONE CRIMPED SEALED SUPPLEMENT VIAL WERE PLACED INTO THE 20-25-DEGREE CELSIUS INCUBATOR. ONE UNCRIMPED AND ONE CRIMP SEALED SUPPLEMENT VIAL WERE PLACED INTO THE 33-37-DEGREES CELSIUS INCUBATOR. AT FOURTEEN DAYS OF INCUBATION NO MICROBIAL GROWTH WAS OBSERVED IN FOUR INCUBATED RETENTION VIALS. FOUR PHOTOS WERE RECEIVED TO ASSIST WITH THIS INVESTIGATION. ONE PHOTO SHOWED KIT CARTON LABEL BATCH 4242482, EXP 2025-12-03. ONE PHOTO SHOWED A STOPPER WITH SLIMY, BLACK MATERIAL ON THE UNDERSIDE OF THE STOPPER. ONE PHOTO SHOWED STOPPERED, UNCRIMPED SUPPLEMENT BATCH 4193147, EXP 2026-01-07. NO RETURNS WERE RECEIVED TO ASSIST WITH THIS INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR THIS COMPLAINT. NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, AN UNSPECIFIED NUMBER OF SIRE SUPPLEMENT VIALS CONTAINED BIOLOGICAL CONTAMINATION DESCRIBED AS "BLACK MOLD." THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, AN UNSPECIFIED NUMBER OF SIRE SUPPLEMENT VIALS CONTAINED BIOLOGICAL CONTAMINATION DESCRIBED AS "BLACK MOLD." THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724298 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) 4242482 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown