BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 22363237 · Received June 30, 2025

    Report

    Report Number
    1119779-2025-00748
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 5, 2025
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, CONTAMINATES DESCRIBED AS "BLACK ARTIFACTS" WERE FOUND INSIDE ONE (1) SUPPLEMENT VIAL. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. D1. MEDICAL DEVICE BRAND NAME: BD BACTEC¿ MGIT¿ 960 SIRE KIT. D2A. COMMON DEVICE NAME: SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL. D2B. MEDICAL DEVICE TYPE: MJA. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G4. PMA / 510(K)#: K003062, K014123. INVESTIGATION SUMMARY: 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). FOR THIS PRODUCT, RETENTION SAMPLES ARE MAINTAINED AS INDIVIDUAL COMPONENTS AND NO COMPLETE KITS (MATERIAL 245123) ARE AVAILABLE FOR INSPECTION. THE KIT (245123) BATCH NUMBER IS UNKNOWN; THEREFORE, A BHR REVIEW AND COMPLETE HISTORY REVIEW COULD NOT BE COMPLETED. SIRE SUPPLEMENT BATCH NUMBER 4159885 WAS PROVIDED BY THE CUSTOMER. BATCH HISTORY REVIEW FOR SIRE BATCH 4159885 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING OR INSPECTION. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. NO OTHER COMPLAINTS HAVE BEEN REPORTED ON SIRE SUPPLEMENT COMPONENT BATCH 4159885 FOR CONTAMINATION. THREE PHOTOS WERE PROVIDED FOR INVESTIGATION. ALL THREE PHOTOS RECEIVED SHOWED SIRE SUPPLEMENT VIAL BATCH 4159885 (EXP 2025-12-05) WITH FLOATING MASSES IN THE MEDIA. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. RETENTION SAMPLE INSPECTION OF THE SIRE SUPPLEMENT VIAL BATCH 4159885 IS NOT REQUIRED FOR THIS COMPLAINT AS THE PHOTOS VERIFY THE DEFECT. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION OF SIRE SUPPLEMENT BATCH 4159885 BASED ON THE PHOTOS PROVIDED. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: 4159885 WAS REPORTED; HOWEVER, THIS IS NOT A KIT LOT # MANUFACTURED FOR THE REPORTED CATALOG #. UPDATED TO UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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 BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, CONTAMINATES DESCRIBED AS "BLACK ARTIFACTS" WERE FOUND INSIDE ONE (1) SUPPLEMENT VIAL. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, CONTAMINATES DESCRIBED AS "BLACK ARTIFACTS" WERE FOUND INSIDE ONE (1) SUPPLEMENT VIAL. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129884 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) UNKNOWN 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown