BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 20363968 · Received October 3, 2024

    Report

    Report Number
    1119779-2024-00716
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    August 28, 2024
    Report Date
    December 26, 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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B5. DESCRIBE EVENT: "REPORT 1 OF 2:" WAS ADDED. INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 4120595 IS COMPOSED OF MGIT PANTA BATCH 4088704 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4059621. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 4120595 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 4088704 AND MGIT 960 GROWTH SUPPLEMENT BATCH 4059621 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. RETENTION SAMPLES FROM PANTA BATCH 4088704 (10 VIALS) AND SUPPLEMENT BATCH 4059621 (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 4059621 WERE INCUBATED AT 20 TO 25 DEGREES C (1 VIAL) AND 33 TO 37 DEGREES (1 VIAL). TWO PANTA VIALS FROM BATCH 4088704 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 4088704 WERE RECONSTITUTED WITH 15ML OF SUPPLEMENT FROM BATCH 4059621 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. ONE PHOTO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS A CARTON LABEL FROM BATCH 4120595 FOR BATCH VERIFICATION. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER FACILITY NAME: (B)(6). 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

    REPORT 1 OF 2: IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, AN UNSPECIFIED NUMBER OF SAMPLES WERE FOUND TO BE CONTAMINATED WITH BREVIBACTERIUM CASEI AFTER SUBCULTURING. MALDI IDENTIFICATIONS WERE PERFORMED ON POSITIVE MGIT SAMPLES ALONG WITH MICROSCOPY. IN ADDITION, CONTROL TESTING WAS CONDUCTED AND THE CUSTOMER FOUND THE MGIT GROWTH SUPPLEMENT WAS POSITIVE FOR BREVIBACTERIUM CASEI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, AN UNSPECIFIED NUMBER OF SAMPLES WERE FOUND TO BE CONTAMINATED WITH BREVIBACTERIUM CASEI AFTER SUBCULTURING. MALDI IDENTIFICATIONS WERE PERFORMED ON POSITIVE MGIT SAMPLES ALONG WITH MICROSCOPY. IN ADDITION, CONTROL TESTING WAS CONDUCTED AND THE CUSTOMER FOUND THE MGIT GROWTH SUPPLEMENT WAS POSITIVE FOR BREVIBACTERIUM CASEI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172842 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4120595 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown