BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 11917144 · Received June 1, 2021

    Report

    Report Number
    1025402-2021-00005
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 6, 2021
    Report Date
    November 15, 2021
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 5/13/2021. H.6. INVESTIGATION: 245124 MGIT 960 SUPPLEMENT KIT BATCH 0198641 IS COMPOSED OF MGIT PANTA BATCH 0198633 AND MGIT 960 GROWTH SUPPLEMENT BATCH 0198635. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 0198641 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND THERE ARE NO OTHER COMPLAINT FOR 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 0198641 WERE REVIEWED AND ALL BATCH HISTORY RECORDS WERE SATISFACTORY AT TIME OF RELEASE PER PROCEDURE. PERFORMANCE OF EACH KIT COMPONENT WAS SATISFACTORY PER PROCEDURES. RETENTION SAMPLES WERE INSPECTED FOR SUPPLEMENT BATCH 0198635 (9/9 VIALS) AND PANTA BATCH 0198633 (8/8 VIALS) AND NO CRIMP CAP, VIAL OR MEDIA DEFECTS WERE OBSERVED IN ANY OF THESE RETENTION SAMPLES INSPECTED. FOR FURTHER INVESTIGATION TWO RETENTION SUPPLEMENT VIALS BATCH 0198624 WERE USED TO RECONSTITUTE TWO RETENTION PANTA VIALS BATCH 0198615. THERE WERE NO SIGNS OF FOREIGN MATERIAL SEEN AFTER THE PANTA VIALS WERE RECONSTITUTED. ONE PANTA VIAL WAS THEN INCUBATED IN THE 33-37 DEGREE C INCUBATOR FOR SEVEN DAYS AND ONE PANTA VIAL WAS THEN INCUBATED IN THE 20-25 DEGREE C INCUBATOR. BY THE SEVENTH DAY OF INCUBATION NO SIGNS OF MICROBIAL GROWTH WERE OBSERVED IN EITHER VIAL. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. HOWEVER, RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. BD RECEIVED A BUBBLE WRAPPED PLASTIC BAG INSIDE OF A SHIPPING BOX. INSIDE OF THE PLASTIC BAG WAS A PANTA VIAL FROM BATCH 0198633. THE CRIMP CAP WAS ALREADY REMOVED, AND THE VIAL WAS SEALED WITH PARAFILM. THE VIAL APPEARED TO HAVE BEEN RECONSTITUTED BECAUSE THERE WAS A LITTLE LIQUID INSIDE OF THE VIAL. THERE WAS A TINY FUNGAL LIKE MASS SITTING IN THE VIAL WITH THE BIT OF LIQUID. THE MASS WAS SENT TO THE MICROBIAL LAB FOR IDENTIFICATION. IDENTIFICATION OF THE MASS WAS CONFIRMED AS MOLD. THIS COMPLAINT CAN BE CONFIRMED BY THE RETURN SAMPLE. A TREND HAS NOT BEEN IDENTIFIED, THEREFORE THERE ARE NO ACTIONS PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR FOREIGN MATERIAL. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT FUNGAL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED THAT FM (FUNGAL MASS) WAS FOUND IN TUBE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT FUNGAL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED THAT FM (FUNGAL MASS) WAS FOUND IN TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810312 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB LEE LABORATORIES, INC. 245124 0198641 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown