BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 21309595 · Received February 4, 2025

    Report

    Report Number
    1119779-2025-00031
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 8, 2025
    Report Date
    April 23, 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
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVAL- YES. D9. RETURNED TO MANUFACTURER ON: 24-FEB-2025. H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 4180077 IS COMPOSED OF MGIT PANTA BATCH 4180071 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4180074. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 4180077 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. 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 4180071 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4180074 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE CRIMPED APPROPRIATELY PER INTERNAL PROCEDURE. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. SAMPLES ARE RECONSTITUTED AS APPROPRIATE AND INCUBATED AT 25 C AND AT 35 C FOR 14 DAYS. ALL BIOBURDEN TESTING PERFORMED ON THESE BATCHES WERE SATISFACTORY PER INTERNAL PROCEDURES. RETENTION SAMPLES OF GROWTH SUPPLEMENT BATCH 4180074 (8 VIALS) WERE AVAILABLE FOR INSPECTION. NO MICROBIAL GROWTH WAS OBSERVED IN 8/8 VIALS FROM VISUAL INSPECTION. FOR INVESTIGATION, TWO VIALS FROM BATCH 4180074 WERE INCUBATED AT 23 TO 27 DEGREES C (1 VIAL) AND 33 TO 37 DEGREES C (1 VIAL). NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 VIALS AT 14 DAYS INCUBATION. NO RETENTION SAMPLES OF PANTA BATCH 4180071 WERE AVAILABLE FOR INVESTIGATION. ONE PHOTO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS A RECONSTITUTED PANTA VIAL WITH WHAT APPEARS TO BE MICROBIAL GROWTH IN THE VIAL. NO PRODUCT LABELS WERE VISIBLE IN THE PHOTO FOR BATCH VERIFICATION. RETURN SAMPLE WAS RECEIVED FOR INVESTIGATION. ONE PANTA VIAL FROM BATCH 4180071 IN A PLASTIC BAG WAS RETURNED IN A BOX WITH BUBBLE WRAP. FUNGAL GROWTH WAS OBSERVED IN THE RETURNED VIAL. THE VIAL WAS SUBMITTED TO THE IDENTIFICATION LAB WHERE MOLD WAS CONFIRMED BUT COULD NOT BE FURTHER IDENTIFIED BECAUSE THE MOLD WAS NO LONGER VIABLE. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. THIS PRODUCT DOES NOT HAVE A STERILE CLAIM. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR CONTAMINATION IN THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133863 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4180077 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown