BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC MGIT 960 SUPPLEMENT KIT

    MDR report key: 11599527 · Received March 31, 2021

    Report

    Report Number
    1119779-2021-00594
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    February 5, 2021
    Report Date
    September 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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). DURING THE KIT PACKAGING OF THIS PRODUCT, VIALS ARE VISUALLY EXAMINED MANUALLY. MGIT 960 PANTA BATCH 0230829 WAS PROVIDED FOR INVESTIGATION OF THIS COMPLAINT. THE BATCH HISTORY RECORD REVIEW FOR PANTA BATCH 0230829 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED. FILLING, CRIMPING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE CRIMPED APPROPRIATELY PER PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. IF FOREIGN MATTER HAD BEEN NOTED DURING QC TESTING, THE PRODUCT WOULD HAVE BEEN PLACED ON QUALITY NOTIFICATION AND FURTHER ANALYSIS INCLUDING 100% INSPECTION OF THE BATCH WOULD HAVE BEEN CONDUCTED. RETENTION SAMPLES FROM BATCH 0230829 (10 VIALS) WERE AVAILABLE FOR INSPECTION. NO CRIMP, VIAL OR MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION VIALS. FOR FURTHER TESTING OF THE COMPLAINT TWO PANTA VIALS FROM BATCH 0230829 WERE RECONSTITUTED WITH WATER. ONE VIAL WAS PLACED INTO 20-TO-25-DEGREE CELSIUS INCUBATOR AND ONE VIAL WAS PLACED IN THE 33-TO-37-DEGREE CELSIUS INCUBATOR. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. CUSTOMER DID NOT PROVIDE A KIT BATCH NUMBER FOR INVESTIGATION. TRENDING WAS DONE ON THE APPROPRIATE DATABASES FOR BACTEC MGIT 960 SUPPLEMENT (MATERIAL 245124) AND THERE ARE NO QUALITY NOTIFICATIONS TAKEN FOR CONTAMINATION DEFECTS IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 245124 AND THERE IS NO TREND FOR CONTAMINATION ON ANY BATCHES OVER THE LAST 12 MONTHS. BD WILL CONTINUE TO TREND FOR CONTAMINATION ISSUES. THIS COMPLAINT CANNOT BE CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CONTAMINATION. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER WAS SEEING GRAM NEGATIVE RODS IN MGIT TUBES. CUSTOMER PERFORMED QC ON PANTA, AND SEVERAL TIMES, IT GREW METHYLOBACTERIUM. 3 PATIENTS ALSO HAD ORGANISM, BUT IT WAS NOT REPORTED. CUSTOMER DID NOT HAVE THE LOT NUMBER, BUT PROVIDED THE COMPONENT LOT OF 0230829 FOR THE PANTA VIAL."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: CONTAMINATION. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER WAS SEEING GRAM NEGATIVE RODS IN MGIT TUBES. CUSTOMER PERFORMED QC ON PANTA, AND SEVERAL TIMES, IT GREW METHYLOBACTERIUM. 3 PATIENTS ALSO HAD ORGANISM, BUT IT WAS NOT REPORTED. CUSTOMER DID NOT HAVE THE LOT NUMBER, BUT PROVIDED THE COMPONENT LOT OF 0230829 FOR THE PANTA VIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494341 BD BACTEC MGIT 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245124 UNKNOWN 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1