BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 22939960 · Received September 2, 2025

    Report

    Report Number
    1119779-2025-04816
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    November 16, 2024
    Report Date
    July 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 4171070 IS COMPOSED OF MGIT PANTA BATCH 4144308 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4151802. 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 4144308 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4151802 WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. SAMPLES ARE RECONSTITUTED AS APPROPRIATE AND ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR 14 DAYS. ALL BIOBURDEN TESTING PERFORMED ON THESE COMPONENTS BATCH WAS SATISFACTORY PER INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED AND NO OTHER COMPLAINTS WERE RECEIVED FOR MGIT 960 SUPPLEMENT KIT BATCH 4171070. RETENTION SAMPLES FROM PANTA BATCH 4144308 (10 VIALS) AND SUPPLEMENT BATCH 4151802 (10 VIALS) WERE AVAILABLE FOR INSPECTION. NO MICROBIAL GROWTH WAS OBSERVED FROM VISUAL INSPECTION OF THE AVAILABLE SAMPLES. FOR INVESTIGATION OF THIS COMPLAINT, TWO UNOPENED VIALS OF SUPPLEMENT BATCH 4151802 WERE INCUBATED AT 20 TO 25 DEGREES C (1 VIAL) AND 33 TO 37 DEGREES (1 VIAL). TWO PANTA VIALS FROM BATCH 4144308 WERE RECONSTITUTED WITH STERILE WATER AND INCUBATED AT 20 TO 25 DEGREES C (1 VIAL) AND 33 TO 37 DEGREES C (1 VIAL). FINALLY, TWO PANTA VIALS FROM BATCH 4144308 WERE RECONSTITUTED WITH 15ML OF SUPPLEMENT FROM BATCH 4151802 AND INCUBATED AT 20 TO 25 DEGREES C (1 RECONSTITUTED PANTA AND 1 VIAL OF REMAINING SUPPLEMENT) AND 33 TO 37 DEGREES C (1 RECONSTITUTED PANTA AND 1 VIAL OF REMAINING SUPPLEMENT). AT SEVEN DAYS INCUBATION, 0/8 VIALS INCUBATED HAD MICROBIAL GROWTH. NO PHOTOS OR RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO COMPLAINT TREND FOR HAS BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189287 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4171070 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown