BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC MGIT 960 SUPPLEMENT KIT

    MDR report key: 11720939 · Received April 23, 2021

    Report

    Report Number
    1119779-2021-00705
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    October 6, 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
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : MGIT 960 SUPPLEMENT KIT BATCH 0171932 IS COMPOSED OF MGIT PANTA BATCH 0171921 AND MGIT 960 GROWTH SUPPLEMENT BATCH 0171922. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 0171932 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH FOR CONTAMINATION. 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 0171932 WERE REVIEWED AND ALL BATCH HISTORY RECORDS WERE SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. PERFORMANCE OF EACH KIT COMPONENT WAS SATISFACTORY PER PROCEDURES. RETENTION SAMPLES WERE INSPECTED FOR SUPPLEMENT BATCH 0171922 (10 VIALS) AND PANTA BATCH 0171921 (10 VIALS) NO CRIMP, VIAL OR MEDIA DEFECTS WERE OBSERVED IN ANY OF THESE RETENTION SAMPLES INSPECTED. FOR FURTHER TESTING TWO RETENTION SUPPLEMENT VIAL BATCH 0171922 WERE USED TO RECONSTITUTE TWO RETENTION PANTA VIALS BATCH 0171921 AND NO SIGNS OF CONTAMINATION WERE SEEN AFTER RECONSTITUTION. ONE PANTA VIAL WAS THEN INCUBATED IN THE 33-37 DEGREE C INCUBATOR FOR SEVEN DAYS; AND ONE PANTA VIAL WAS PLACED IN THE 20-25 DEGREE C INCUBATOR FOR SEVEN DAYS. BY THE SEVENTH DAY OF INCUBATION, NO SIGNS OF MICROBIAL GROWTH WERE OBSERVED IN THE VIALS. TWO PANTA VIALS FROM BATCH 0171921 WERE ALSO RECONSTITUTED WITH DI WATER, FOR ADDITIONAL TESTING AND INCUBATED FOR SEVEN DAYS. ONE PANTA VIAL WITH DI WATER WAS INCUBATED IN THE 33-37 DEGREE C INCUBATOR FOR SEVEN DAYS; AND ONE PANTA VIAL WITH DI WATER WAS PLACED IN THE 20-25 DEGREE C INCUBATOR FOR SEVEN DAYS. BY THE SEVENTH DAY OF INCUBATION NO MICROBIAL GROWTH WAS OBSERVED. THREE PHOTOS WERE RECEIVED IN LIEU OF RETURNS TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS A RECONSTITUTED PANTA VIAL WITH FOREIGN MATERIAL INSIDE OF THE VIAL THAT APPEARS TO BE FUNGAL GROWTH. THE PANTA VIAL IS FROM BATCH 0171921. THE SUPPLEMENT VIAL FROM BATCH 0171922 IS NEXT TO THE PANTA VIAL. THE CRIMP CAPS HAVE BEEN REMOVED FROM BOTH VIALS. THE SECOND PHOTO IS SIMILAR TO THE FIRST PHOTO. THE PANTA VIAL FROM BATCH 0171921 IS RECONSTITUTED POSSIBLY FROM THE SUPPLEMENT VIAL 0171922 (WHICH IS NEXT TO THE PANTA VIAL IN THE PHOTO). BOTH CRIMP CAPS HAVE BEEN REMOVED. THE FOREIGN OBJECT INSIDE OF THE PANTA VIAL APPEARS TO BE FUNGAL. THE LAST PHOTO VERIFIES THE PANTA BATCH AS 0171921 AND SUPPLEMENT VIAL BATCH AS 0171922. A TREND HAS NOT BEEN IDENTIFIED, THEREFORE, NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. THIS COMPLAINT CAN BE CONFIRMED BY THE PHOTOS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT FOREIGN MATTER WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MILDEW."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT FOREIGN MATTER WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MILDEW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611641 BD BACTEC MGIT 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245124 0171932 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1