BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 17119972 · Received June 13, 2023

    Report

    Report Number
    1119779-2023-00644
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 15, 2023
    Report Date
    July 19, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2023-06-14. H.6 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). PANTA BATCH NUMBER 3033253 WAS PROVIDED BY THE CUSTOMER. BATCH HISTORY REVIEW FOR PANTA BATCH 3033253 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTIONS WERE AVAILABLE FOR INSPECTION FOR PANTA BATCH 3033253 (10 VIALS). NO MEDIA DEFECTS WERE OBSERVED IN 10/10 PANTA RETENTION SAMPLES. FOR FURTHER INVESTIGATION TWO PANTA VIALS FROM BATCH 3033253 WAS RECONSTITUTED WITH TWO SUPPLEMENT VIALS FROM BATCH 3033261. ONE PANTA VIAL RECONSTITUTED WITH SUPPLEMENT (REMAINING SUPPLEMENT INSIDE THE SUPPLEMENT VIAL WAS ALSO INCUBATED) WAS PLACED INTO 20-25-DEGREES CELSIUS INCUBATION; AND ONE PANTA VIAL RECONSTITUTED WITH SUPPLEMENT (REMAINING SUPPLEMENT INSIDE OF THE SUPPLEMENT VIAL WAS ALSO INCUBATED) WAS PLACED INTO 33-37-DEGREES CELSIUS INCUBATION. AT THE END OF A FOURTEEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 4/4 INCUBATED RETENTION VIALS. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: BOTH PHOTOS SHOW AN UNCRIMPED AND RECONSTITUTED PANTA VIAL FROM BATCH 3033253. THERE DOES APPEAR TO BE GROWTH IN THE VIAL. NO RETURNS WERE RECEIVED FOR THE INVESTIGATION. NO 245124-KIT BATCH NUMBER WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. HOWEVER, MANUFACTURING RECORDS FOR PANTA BATCH 3033253 WERE REVIEWED AND A PROBABLE KIT BATCH NUMBER WAS FOUND. REVIEW OF THE PROBABLE KIT BATCH NUMBER FOUND THE KIT PACKAGING PROCESS WAS SATISFACTORY AND THERE ARE NO COMPLAINTS TAKEN ON THE PROBABLE KIT BATCH. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION ISSUES. THIS COMPLAINT CANNOT BE CONFIRMED FOR A DEFECT IN A 245124 KIT.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN . 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 THAT WHILE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND COTTONY GROWTH SUSPENDED IN VIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND COTTONY GROWTH SUSPENDED IN VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215196 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245124 UNKNOWN 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown