BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 20054637 · Received August 23, 2024

    Report

    Report Number
    1119779-2024-00636
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 25, 2024
    Report Date
    December 9, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 4011834 IS COMPOSED OF MGIT PANTA BATCH 4011816 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4011821. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 4011834 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH 4011834. 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 COMPONENTS OF KIT BATCH 4011834 WERE REVIEWED AND ALL BATCH HISTORY RECORDS WERE SATISFACTORY AT TIME OF RELEASE PER INTERNAL PROCEDURES. PERFORMANCE OF EACH KIT COMPONENT WAS SATISFACTORY PER PROCEDURES. RETENTION SAMPLES WERE INSPECTED FOR GROWTH SUPPLEMENT BATCH 4011821 AND PANTA BATCH 4011816 WERE NOT AVAILABLE. THERE WERE TWO PHOTOS SUBMITTED TO ASSIST DURING THIS INVESTIGATION. BOTH PHOTOS SHOW CONTAMINATION, HOWEVER THE BATCH NUMBER IN VIEW FOR THE GROWTH SUPPLEMENT IS FROM BATCH 3208510 WITH EXPIRATION 2025-01-23. THIS BATCH NUMBER IS NOT ASSOCIATED WITH THE KIT BATCH IN WHICH THIS COMPLAINT WAS RECEIVED THEREFORE THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.

    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 GROWTH CONTAMINATION WAS OBSERVED IN SIX (6) SUPPLEMENT BOTTLES. 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 GROWTH CONTAMINATION WAS OBSERVED IN SIX (6) SUPPLEMENT BOTTLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698136 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4011834 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown