BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 21643090 · Received March 19, 2025

    Report

    Report Number
    1119779-2025-00198
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 19, 2025
    Report Date
    May 1, 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
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - MGIT 960 SUPPLEMENT KIT BATCH 4221626 IS COMPOSED OF MGIT PANTA BATCH 4221619 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4221624. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 4221626 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON THIS KIT BATCH 4221626 FOR CONTAMINATION. 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 4221626 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 AVAILABLE FOR THE COMPONENTS; 6 SUPPLEMENT VIALS FROM COMPONENT BATCH 4221624 AND 12 VIALS OF PANTA FROM COMPONENT BATCH 4221619. TWO VIALS OF PANTA COMPONENT WAS RECONSTITUTED WITH 10ML OF SUPPLEMENT AND INCUBATED ALONGSIDE THE REMAINING SUPPLEMENT FOR 14 DAYS AT EACH 20-25C AND 30-35C. AT THE END OF 14 DAYS INCUBATION, THERE WAS NO CONTAMINATION OBSERVED IN ANY OF THE INCUBATED VIALS. THERE WERE TWO (2) PHOTOS RECEIVED TO ASSIST WITH THE INVESTIGATION. THE PHOTO SHOWS A CONTAMINATED BOTTLE OF PANTA WITH BATCH VERIFICATION FOR PANTA COMPONENT BATCH 4221619 WITH EXPIRATION 20206-02-11. THERE WERE NO RETURNS AVAILABLE TO ASSIST WITH THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, ONE (1) SUPPLEMENT BOTTLE WAS OBSERVED TO HAVE CONTAMINATION DESCRIBED AS "IMPURITIES." THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, ONE (1) SUPPLEMENT BOTTLE WAS OBSERVED TO HAVE CONTAMINATION DESCRIBED AS "IMPURITIES." THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545510 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4221626 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown