BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 17455364 · Received August 3, 2023

    Report

    Report Number
    1025402-2023-00034
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 19, 2023
    Report Date
    September 7, 2023
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.7 INITIAL REPORTER ADDR 1: (B)(6). H.3. 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

    H.6. INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 3061087 IS COMPOSED OF MGIT PANTA BATCH 3061040 AND 960 GROWTH SUPPLEMENT BATCH 3061057. 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 3061040 AND MGIT 960 GROWTH SUPPLEMENT BATCH 3061057 WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAVE BEEN TAKEN ON BATCH 3061087. RETENTIONS FOR PANTA BATCH 3061040 (10 VIALS) AND GROWTH SUPPLEMENT BATCH 3061057 (6 VIALS) WERE AVAILABLE FOR INSPECTION. FOR PANTA BATCH 3061087, ALL 10/10 RETENTION VIALS HAD NO DEFECTS OR DAMAGE FROM VISUAL INSPECTION. FOR GROWTH SUPPLEMENT BATCH 3061057, ALL 3/3 RETENTION VIALS HAD NO DEFECTS OR DAMAGE FROM VISUAL INSPECTION. FOR FURTHER INVESTIGATION, TWO GROWTH SUPPLEMENT VIALS WERE USED TO RECONSTITUTE TWO PANTA VIALS. ONE RECONSTITUTED PANTA VIAL AND THE GROWTH SUPPLEMENT VIAL WITH REMAINING MEDIA WERE INCUBATED AT 33 TO 37 DEGREES CELSIUS AND THE OTHER RECONSTITUTED PANTA VIAL AND GROWTH SUPPLEMENT VIAL WITH REMAINING MEDIA WERE INCUBATED AT 20 TO 25 DEGREES CELSIUS. AT THE FOURTEEN DAYS INCUBATION, NO MICROBIAL GROWTH WAS OBSERVED IN 4/4 INCUBATED RETENTION VIALS. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS A PARTIAL CLOSED KIT CARTON FROM BATCH 3061087. THE SECOND PHOTO SHOWS A PARTIAL SUPPLEMENT VIAL FROM BATCH 3061057 (THE CRIMP CAP CANNOT BE SEEN FROM THE PHOTO) THERE APPEARS TO BE POSSIBLE FUNGAL GROWTH IN THE MEDIA. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS RECEIVED. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CONTAMINATION IN SUPPLEMENT KIT VIAL FINDING OF FUNGAL BALLS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CONTAMINATION IN SUPPLEMENT KIT VIAL FINDING OF FUNGAL BALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657662 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB LEE LABORATORIES, INC. 3061087 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown