BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 15222131 · Received August 12, 2022

    Report

    Report Number
    1025402-2022-00006
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    May 11, 2022
    Report Date
    August 16, 2022
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MGIT 960 SUPPLEMENT KIT BATCH 1271214 IS COMPOSED OF MGIT PANTA BATCH 1266134 AND MGIT 960 GROWTH SUPPLEMENT BATCH 1260725. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 1271214 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 1266134 WAS SATISFACTORY PER INTERNAL PROCEDURES AND MGIT 960 GROWTH SUPPLEMENT BATCH 1260725 WAS SATISFACTORY PER INTERNAL PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTIONS FOR PANTA BATCH 1266134 (6 VIALS) AND GROWTH SUPPLEMENT BATCH 1260725 (2 VIALS) WERE AVAILABLE FOR INSPECTION. ALL RETENTION VIALS MAINTAINED HAD NO EVIDENCE OF CONTAMINATION FROM VISUAL INSPECTION. FOR INVESTIGATION, TWO RETENTION PANTA VIALS BATCH 1266134 WERE RECONSTITUTED (PER PROCEDURE) WITH TWO GROWTH SUPPLEMENT VIALS FROM BATCH 1260725. ONE RECONSTITUTED PANTA VIAL AND REMAINING GROWTH SUPPLEMENT WERE INCUBATED AT 33-35-DEGREES CELSIUS; AND ONE RECONSTITUTED PANTA AND REMAINING SUPPLEMENT VIAL WERE INCUBATED AT 20-25-DEGREE CELSIUS. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 4/4 RETENTION VIALS. THREE PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS A CLOSED KIT CARTON FROM KIT BATCH 1271214. A RECONSTITUTED PANTA VIAL IS ON TOP OF THE KIT CARTON. THE PANTA VIAL IS PARAFILM AROUND THE STOPPER THE VIAL APPEARS TO BE UNCRIMPED. THERE DOES APPEAR TO BE FUNGAL GROWTH IN THE VIAL. THE SECOND PHOTO SHOWS A PARTIAL CLOSED KIT CARTON FROM KIT BATCH 1271214. THERE IS A PARTIAL RECONSTITUTED PANTA VIAL FROM BATCH 1266134. THERE DOES APPEAR TO BE FUNGAL GROWTH IN THE VIAL. THE LAST PHOTO SHOWS AN OPENED KIT CARTON. TWO SUPPLEMENT VIALS ARE STILL CRIMP CAPPED SEALED IN THE PACKAGING INSERT. ONE RECONSTITUTED PANTA FROM BATCH 1266134 IS SITTING ON TOP OF THE PACKAGING INSERT. THE RECONSTITUTED PANTA VIAL IS WRAPPED IN PARAFILM. THERE DOES APPEAR TO BE FUNGAL GROWTH IN THE VIAL. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE COMPLAINT CAN BE CONFIRMED BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: "MGIT 960 SUPPLEMENT KIT BATCH 1271214 IS COMPOSED OF MGIT PANTA BATCH 1266134 AND MGIT 960 GROWTH SUPPLEMENT BATCH 1260725. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 1271214 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 1266134 WAS SATISFACTORY PER INTERNAL PROCEDURES AND MGIT 960 GROWTH SUPPLEMENT BATCH 1260725 WAS SATISFACTORY PER INTERNAL PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTIONS FOR PANTA BATCH 1266134 (6 VIALS) AND GROWTH SUPPLEMENT BATCH 1260725 (2 VIALS) WERE AVAILABLE FOR INSPECTION. ALL RETENTION VIALS MAINTAINED HAD NO EVIDENCE OF CONTAMINATION FROM VISUAL INSPECTION. FOR INVESTIGATION, TWO RETENTION PANTA VIALS BATCH 1266134 WERE RECONSTITUTED (PER PROCEDURE) WITH TWO GROWTH SUPPLEMENT VIALS FROM BATCH 1260725. ONE RECONSTITUTED PANTA VIAL AND REMAINING GROWTH SUPPLEMENT WERE INCUBATED AT 33-35-DEGREES CELSIUS; AND ONE RECONSTITUTED PANTA AND REMAINING SUPPLEMENT VIAL WERE INCUBATED AT 20-25-DEGREE CELSIUS. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 4/4 RETENTION VIALS. THREE PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS A CLOSED KIT CARTON FROM KIT BATCH 1271214. A RECONSTITUTED PANTA VIAL IS ON TOP OF THE KIT CARTON. THE PANTA VIAL IS PARAFILM AROUND THE STOPPER THE VIAL APPEARS TO BE UNCRIMPED. THERE DOES APPEAR TO BE FUNGAL GROWTH IN THE VIAL. THE SECOND PHOTO SHOWS A PARTIAL CLOSED KIT CARTON FROM KIT BATCH 1271214. THERE IS A PARTIAL RECONSTITUTED PANTA VIAL FROM BATCH 1266134. THERE DOES APPEAR TO BE FUNGAL GROWTH IN THE VIAL. THE LAST PHOTO SHOWS AN OPENED KIT CARTON. TWO SUPPLEMENT VIALS ARE STILL CRIMP CAPPED SEALED IN THE PACKAGING INSERT. ONE RECONSTITUTED PANTA FROM BATCH 1266134 IS SITTING ON TOP OF THE PACKAGING INSERT. THE RECONSTITUTED PANTA VIAL IS WRAPPED IN PARAFILM. THERE DOES APPEAR TO BE FUNGAL GROWTH IN THE VIAL. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE COMPLAINT CAN BE CONFIRMED BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ANALYZING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, BIOLOGICAL CONTAMINATION WAS OBSERVED. THERE WERE NO RESULTS REPORTED TO PHYSICIANS AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINED DETECTIVE ADDITIVE OF MGIT SUPPLEMENT DEFECTIVE (FOREIGN MATTER).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ANALYZING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, BIOLOGICAL CONTAMINATION WAS OBSERVED. THERE WERE NO RESULTS REPORTED TO PHYSICIANS AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER COMPLAINED DETECTIVE ADDITIVE OF MGIT SUPPLEMENT DEFECTIVE ( FOREIGN MATTER)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070862 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB LEE LABORATORIES, INC. 245124 1271214 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown