BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 22559683 · Received July 21, 2025

    Report

    Report Number
    1119779-2025-01777
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 28, 2025
    Report Date
    September 26, 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

    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 INVESTIGATION, 12 RETENTION SAMPLES OF MGIT 960 SIRE SUPPLEMENT BATCH 4193147 WERE INSPECTED. NONE OF THE 12 SAMPLES CONTAINED CONTAMINATION OR FOREIGN MATTER. FOR FURTHER INVESTIGATION, 2 SETS OF 2 VIALS OF SIRE SUPPLEMENT FROM BATCH 4193147 WERE INCUBATED: 2 VIALS AT 20-25 DEGREES CELSIUS AND 2 VIALS AT 33-37 DEGREES CELSIUS. EACH SET OF TWO CONTAINED 1 SUPPLEMENT VIAL THAT WAS LEFT WITH THE METAL CRIMP CAP AND RUBBER SEPTUM INTACT, WHILE THE OTHER VIALS' METAL CRIMP CAP WAS REMOVED. AT FOURTEEN DAYS OF INCUBATION, NO MICROBIAL GROWTH WAS OBSERVED IN 4/4 INCUBATED RETENTION VIALS. THERE ARE 5 PHOTOS AVAILABLE FOR THIS INVESTIGATION. ONE PHOTO IS OF 2 BOXES, LABEL SIDE UP, WHERE BATCH NUMBER 4242482 AND BD MATERIAL NUMBER 245123, CAN BE OBSERVED. ANOTHER PHOTO SHOWS TWO BOXES STACKED, WITH A PLASTIC BAG ON TOP, WHICH APPEARS TO CONTAIN SEVERAL VIALS OF BD PRODUCT. A THIRD PHOTO SHOWS TWO BOXES OF BD MATERIAL 245123 AND A PLASTIC BAG CONTAINING SEVERAL VIALS OF BD PRODUCT, WHERE BATCH NUMBER 4193147 ON ONE OF THE VIALS, IS VISIBLE THROUGH THE PLASTIC. TWO OTHER PICTURES SHOW A BROWN VIAL WITH ITS METAL CRIMP CAP REMOVED AND RUBBER STOPPER IN PLACE. THE VIALS ARE HELD AT DIFFERENT ANGLES, AND FOREIGN MATERIAL IS VISIBLE INSIDE THE VIAL. THIS COMPLAINT IS CONFIRMED; HOWEVER, NO ACTIONS ARE INDICATED AT THIS TIME AS THE DEFECT COULD NOT BE IDENTIFIED OR REPLICATED BY EVALUATION OF BD RETENTION SAMPLES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION AND PRESENCE OF FOREIGN MATERIAL. NOTE: A REVIEW OF THIS FAILURE HAS CONFIRMED THE EVENT IS NOT LIKELY TO CONTRIBUTE TO A SERIOUS INJURY OR DEATH WITH THE RATIONALE BELOW. THIS REPORT WILL BE THE FINAL SUBMITTED FOR THIS FAILURE. BD HAS REVIEWED 2 YEARS OF DATA ASSOCIATED WITH THE FAILURE AND DETERMINED THAT THE FAILURE HAS NOT CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THE IFU STATES THE BROTH SHOULD APPEAR CLEAR AND COLORLESS AND TO NOT USE IF TURBID. THIS TURBIDITY MAY SETTLE DURING TRANSPORT AND MAY APPEAR AS A PRECIPITATE. WHEN CONTAMINATION IS NOTICED PRIOR TO USE, IT WOULD REQUIRE THE USER TO ACQUIRE REPLACEMENT MATERIAL AND IS UNLIKELY TO RESULT IN SERIOUS INJURY.

    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

    REPORT 2 OF 2. IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, CONTAMINATION WAS OBSERVED FLOATING IN ONE (1) REAGENT BOTTLE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 2: IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, CONTAMINATION WAS OBSERVED FLOATING IN ONE (1) REAGENT BOTTLE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737547 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