BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 18314649 · Received December 12, 2023

    Report

    Report Number
    1025402-2023-00045
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 15, 2023
    Report Date
    August 2, 2024
    Manufacturer
    LEE LABORATORIES, INC.
    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

    INVESTIGATION SUMMARY: 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). MGIT 960 SUPPLEMENT KIT BATCH 3131669 IS COMPOSED OF MGIT LABEL BATCH 3131649 AND MGIT 960 GROWTH SUPPLEMENT BATCH 3131664. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 3131669 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. RETENTION SAMPLES FROM BATCH 3131649 (10 VIALS) AND 313664 (6 VIALS) WERE AVAILABLE FOR INSPECTION. NO MICROBIAL GROWTH/IMPURITIES WERE FOUND ON ANY OF THE RETENTION VIALS FROM VISUAL INSPECTION. FOR INVESTIGATION, TWO RETENTION VIALS OF PANTA WERE RECONSTITUTED WITH 10ML FROM TWO VIALS OF RETENTION GROWTH SUPPLEMENT. ONE VIAL OF RECONSTITUTED PANTA AND THE VIAL OF REMAINING GROWTH SUPPLEMENT WERE INCUBATED AT 20 TO 25 DEGREES C. LIKEWISE, ONE VIAL OF RECONSTITUTED PANTA AND THE VIAL OF REMAINING GROWTH SUPPLEMENT WERE INCUBATED AT 30 TO 35 DEGREES C. NO MICROBIAL GROWTH WAS OBSERVED IN THE 4 VIALS AT 7 DAYS INCUBATION. THREE (3) PHOTOS WERE AVAILABLE FOR REVIEW FOR THIS COMPLAINT. THE FIRST PHOTO SHOWS A BOTTLE FROM BATCH 3131649 WITH EXPIRATION 2024-11-03. THE LIQUID IN THE BOTTLE SHOWS MICROBIAL GROWTH. THE SECOND PHOTO SHOWS A SINGLE UNCRIMPED BOTTLE. THE MATERIAL NUMBER, BATCH NUMBER AND EXPIRATION DATE ARE NOT IN VIEW. THE THIRD PHOTO SHOWS A SINGLE UNCRIMPED BOTTLE FROM BATCH 3131664 WITH EXPIRATION DATE 2024-11-06. NO RETURNS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE PHOTOS AVAILABLE. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE IDENTIFIED AT THIS TIME. BD WILL CONTINUE TO TREND FOR DEFECTS.

    Additional Manufacturer Narrative · 0

    H.3. 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 CUSTOMER REPORTS THAT THERE WERE IMPURITIES INSIDE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT CUSTOMER REPORTS THAT THERE WERE IMPURITIES INSIDE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693919 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB LEE LABORATORIES, INC. 3131669 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown