BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 20695555 · Received November 15, 2024

    Report

    Report Number
    1119779-2024-00897
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 16, 2024
    Report Date
    March 10, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 23-DEC-2024. INVESTIGATION SUMMARY MGIT 960 SUPPLEMENT KIT BATCH 4110715 IS COMPOSED OF MGIT PANTA BATCH 4110710 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4110714. MGIT PANTA IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED 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 STANDARD OPERATING PROCEDURES (SOP). MGIT 960 GROWTH 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 SOP. SIX MGIT PANTA VIALS ARE THEN MANUALLY PACKAGED WITH SIX MGIT GROWTH SUPPLEMENT VIALS TO MAKE A MGIT 960 SUPPLEMENT KIT (MATERIAL 245124). THE BATCH HISTORY RECORD REVIEWS FOR MGIT PANTA BATCH 4110710 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4110714 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND TWO OTHER COMPLAINTS HAVE BEEN TAKEN ON 245124 KIT BATCH 4110715. THERE WERE NO RETENTION SAMPLES AVAILABLE TO ASSIST WITH THIS INVESTIGATION. THREE PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE PHOTOS SHOW A MGIT PANTA BATCH 4110710 VIAL. ONE OF THE PHOTOS SHOWS GROWTH FLOATING IN THE MEDIA. RETURNS WERE RECEIVED FOR THE INVESTIGATION. ONE VIAL PANTA WITH PARAFILM COVERING STOPPER BATCH 4110710 WITH GROWTH FLOATING IN MEDIA THIS COMPLAINT CAN BE CONFIRMED. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND FOR DEFECTS.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. 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 WHEN USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THE CUSTOMER NOTICED BIOLOGICAL CONTAMINATION AFTER RECONSTITUTION OF REAGENTS. THIS EVENT OCCURRED WITH ONE (1) KIT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THE CUSTOMER NOTICED BIOLOGICAL CONTAMINATION AFTER RECONSTITUTION OF REAGENTS. THIS EVENT OCCURRED WITH ONE (1) KIT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143760 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4110715 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown