BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 21102159 · Received January 8, 2025

    Report

    Report Number
    1119779-2024-01064
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 9, 2024
    Report Date
    March 20, 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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - MGIT 960 SUPPLEMENT KIT BATCH 4163347 IS COMPOSED OF MGIT PANTA BATCH 4131612 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4144310. 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 4163347 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. THE BATCH HISTORY RECORD REVIEWS FOR MGIT PANTA BATCH 4131612 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4144310 WERE ALSO SATISFACTORY PER INTERNAL PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAS BEEN TAKEN ON KIT BATCH 4163347. FOUR PHOTOS WERE RECEIVED FOR INVESTIGATION. PHOTOS SHOW FUNGAL CONTAMINATION IN A BOTTLE OF BBL MGIT PANTA (BATCH: 4131612). NO RETURNS WERE RECEIVED FOR INVESTIGATION. RETENTION SAMPLES MAINTAINED FOR THIS PRODUCT INCLUDE THE INDIVIDUAL COMPONENTS BUT NOT THE KITTED CONFIGURATION, SO RETENTION SAMPLE INSPECTION IS NOT INDICATED FOR THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE PHOTOS PROVIDED. THERE WERE NO TRENDS IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS.

    Additional Manufacturer Narrative · 0

    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 SUPPLEMENT KIT, FUNGAL CONTAMINATION WAS OBSERVED IN A GROWTH SUPPLEMENT BOTTLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, FUNGAL CONTAMINATION WAS OBSERVED IN A GROWTH SUPPLEMENT BOTTLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105206 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4163347 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown