BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 13232514 · Received January 11, 2022

    Report

    Report Number
    1025402-2021-00011
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 17, 2021
    Report Date
    August 24, 2022
    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

    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 1161188 IS COMPOSED OF MGIT PANTA BATCH 1161152 AND MGIT 960 GROWTH SUPPLEMENT BATCH 1154511. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 1161188 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 1161152 AND MGIT 960 GROWTH SUPPLEMENT BATCH 1154511 WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTION SAMPLES FROM PANTA BATCH 1161152 (10 VIALS) WERE AVAILABLE FOR INSPECTION. NO MICROBIAL GROWTH WAS OBSERVED FROM VISUAL INSPECTION OF 10/10 RETENTION VIALS. RETENTION SAMPLES FROM GROWTH SUPPLEMENT BATCH 1154511 (6 VIALS) WERE AVAILABLE FOR INSPECTION. NO MICROBIAL GROWTH WAS OBSERVED IN 6/6 RETENTION SAMPLES FROM VISUAL INSPECTION. FOR INVESTIGATION OF THE COMPLAINT, ONE PANTA RETENTION VIALS WAS RECONSTITUTED WITH ONE GROWTH SUPPLEMENT RETENTION VIAL AS PER THE PACKAGE INSERT INSTRUCTIONS FOR THIS KIT PRODUCT AND INCUBATED AT 20 TO 25 DEGREES C. ANOTHER PANTA RETENTION VIAL WAS RECONSTITUTED WITH ONE GROWTH SUPPLEMENT RETENTION VIAL AND INCUBATED AT 33 TO 37 DEGREES C. AT SEVEN DAYS INCUBATION, NO GROWTH WAS OBSERVED IN THE VIALS INCUBATED. RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. ONE PANTA VIAL FROM BATCH 1161152 IN A PLASTIC BAG WAS RETURNED IN A BOX WITH PACKAGING PEANUTS AND BUBBLE WRAP. THE CRIMP AROUND THE STOPPER OF THE VIAL HAD BEEN REMOVED AND THE MEDIA WAS RECONSTITUTED. WITHIN THE VIAL, FUNGAL GROWTH WAS OBSERVED. THE VIAL WAS SUBMITTED TO THE ID LAB AND THE FUNGAL GROWTH WAS IDENTIFIED AS A MOLD BUT WAS NO LONGER VIABLE FOR FURTHER IDENTIFICATION. FOUR PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. TWO PHOTOS EACH SHOWS A PANTA VIAL WITH RECONSTITUTED MEDIA. ANOTHER PHOTO SHOWS A CLOSE-UP OF THE RECONSTITUTED MEDIA IN A VIAL FROM BATCH 1161152 WITH WHAT APPEARS TO BE FUNGAL GROWTH FEATURED IN THE MEDIA. THE LAST PHOTO FEATURES THE BATCH INFORMATION OF THE VIAL LABEL FROM BATCH 1161152. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. A COMPLAINT TREND FOR CONTAMINATION WAS IDENTIFIED ON KIT BATCH 1161188. INVESTIGATION OF THE TREND FOUND MOLD FROM ENVIRONMENTAL MONITORING DURING PRODUCTION OF GROWTH SUPPLEMENT BATCH 1154511. THE MOLD OBSERVED DURING ENVIRONMENTAL MONITORING DID NOT EXCEED LEVELS TO TRIGGER AN ACTION PER BD PROCEDURES. DUE TO THE COMPLAINT TREND, MANUFACTURING OPERATIONS INVESTIGATED THE OBSERVED MOLD AND DID NOT FIND A ROOT CAUSE. MANUFACTURING OPERATIONS CONDUCTED A RETRAINING EVENT WITH MANUFACTURING ASSOCIATES FOR ASEPTIC TECHNIQUE AND IN-PROCESS BIOBURDEN REDUCTION AS A CORRECTIVE ACTION. MANUFACTURING OPERATIONS ALSO IDENTIFIED OPPORTUNITIES FOR IMPROVEMENT THAT ARE BEING INVESTIGATED AS WELL. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT HAS BEEN FOUND CONTAINING FOREIGN MATTER. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTER. THE CUSTOMER FOUND LARGE FLOATING MATTER IN THE LIQUID BEFORE USAGE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT HAS BEEN FOUND CONTAINING FOREIGN MATTER. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTER. THE CUSTOMER FOUND LARGE FLOATING MATTER IN THE LIQUID BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584287 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT BLOOD CULTURE BROTH KIT MDB LEE LABORATORIES, INC. 245124 1161188 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown