BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 16882202 · Received May 5, 2023

    Report

    Report Number
    1025402-2023-00028
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 13, 2023
    Report Date
    June 2, 2023
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY MGIT 960 SUPPLEMENT KIT BATCH 2251241 IS COMPOSED OF MGIT PANTA BATCH 2251231 AND MGIT 960 GROWTH SUPPLEMENT BATCH 2251236. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 2251241 WAS SATISFACTORY PER INTERNAL PROCEDURES 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 COMPONENTS OF KIT BATCH 2251241 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 INSPECTED FOR SUPPLEMENT BATCH 2251236 (6 VIALS) AND PANTA BATCH 2251231 (10 VIALS) AND NO MEDIA DEFECTS WERE OBSERVED IN ANY OF THESE RETENTION SAMPLES INSPECTED. FOR FURTHER INVESTIGATION TWO PANTA VIALS FROM BATCH 2251231 WERE RECONSTITUTED WITH TWO SUPPLEMENT VIALS FROM BATCH 2251236. ONE PANTA RECONSTITUTED WITH SUPPLEMENT WAS INCUBATED AT 20-25-DEGREES CELSIUS (THE REMAINING SUPPLEMENT WAS ALSO INCUBATED) AND ONE PANTA WITH SUPPLEMENT WAS INCUBATED AT 33-37-DEGREES CELSIUS (THE REMAINING SUPPLEMENT WAS ALSO INCUBATED). AT THE END OF A FOURTEEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 4/4 INCUBATED RETENTION VIALS. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION: THE PHOTO SHOWS AN UNCRIMPED RECONSTITUTED PANTA VIAL. THERE DOES APPEAR TO BE POSSIBLE FUNGAL GROWTH THROUGHOUT THE MEDIA. NO BATCH INFORMATION IS PRESENTED IN THE PHOTO RECEIVED. WITHOUT PRODUCT VERIFICATION A PHOTO ALONE CANNOT CONFIRM A COMPLAINT. A PHOTO MUST PROVIDE THE PRODUCT, PRODUCT DEFECT, AND IMPORTANT INFORMATION SUCH AS BATCH/LOT NUMBER MUST BE INCLUDED IN THE PHOTO. THE BATCH/LOT NUMBER NEEDS TO BE CLEARLY VISIBLE IN THE PHOTO. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT ONE BOTTLE HAD FUNGAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DEPARTMENT OF AGRICULTURE HAD MADE A PRODUCT COMPLAINT TO OUR IRISH DISTRIBUTOR AQUILANT. AS USUAL, THE PANTA SUPPLEMENT MIX WAS MADE INTO THREE BOTTLES. TWO WERE FINE BUT THE THIRD BOTTLE HAD FUNGAL CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT ONE BOTTLE HAD FUNGAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DEPARTMENT OF AGRICULTURE HAD MADE A PRODUCT COMPLAINT TO OUR IRISH DISTRIBUTOR AQUILANT. AS USUAL, THE PANTA SUPPLEMENT MIX WAS MADE INTO THREE BOTTLES. TWO WERE FINE BUT THE THIRD BOTTLE HAD FUNGAL CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212306 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB LEE LABORATORIES, INC. 245124 2251241 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown