BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 22330313 · Received June 25, 2025

    Report

    Report Number
    1119779-2025-00672
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 5, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 4242981 IS COMPOSED OF MGIT PANTA BATCH 4213716 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4159925. 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 REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 4242981 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. THE BATCH HISTORY RECORD REVIEWS FOR MGIT PANTA BATCH 4213716 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4159925 WERE ALSO SATISFACTORY PER INTERNAL PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER DUPLICATE COMPLAINT WAS TAKEN ON KIT BATCH 4242981. THE RETENTION SAMPLES FOR THIS BATCH WERE NOT AVAILABLE TO ASSIST WITH THIS COMPLAINT. FOUR PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. THERE WAS ONE PHOTO OF A PANTA VIAL WITH WHITE GROWTHS FLOATING IN MEDIA. ONE PHOTO SHOWED A RECONSTITUTED VIAL WITH A BROWN MATERIAL IN THE MEDIA. TWO PHOTOS SHOWED KIT CARTON LABEL 4242981 EXP 2025-12-10. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED FROM THE PHOTOS FOR CONTAMINATION. NO COMPLAINT TRENDS HAVE BEEN INDICATED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT THAT BIOLOGICAL CONTAMINATION WAS OBSERVED IN ONE PANTA BOTTLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367895 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4242981 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown