BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 17276078 · Received July 6, 2023

    Report

    Report Number
    1025402-2023-00032
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 16, 2023
    Report Date
    August 10, 2023
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 2161308 IS COMPOSED OF MGIT PANTA BATCH 2161204 AND MGIT 960 GROWTH SUPPLEMENT BATCH 2161258. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 2161308 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. THE COMPONENTS OF KIT BATCH 2161308 WERE REVIEWED AND ALL BATCH HISTORY RECORDS WERE SATISFACTORY AT TIME OF RELEASE PER INTERNAL PROCEDURES. PERFORMANCE OF EACH KIT COMPONENT WAS SATISFACTORY PER PROCEDURES. RETENTION SAMPLES WERE INSPECTED FOR SUPPLEMENT BATCH 2161258 (5 VIALS) AND PANTA BATCH 2161204 (10 VIALS) AND NO MEDIA DEFECTS WERE OBSERVED IN ANY OF THESE RETENTION SAMPLES INSPECTED. FOR FURTHER INVESTIGATION, TWO PANTA VIALS WERE RECONSTITUTED WITH TWO SUPPLEMENT VIALS. ONE PANTA RECONSTITUTED WITH SUPPLEMENT (THE REMAINING SUPPLEMENT IN THE SUPPLEMENT VIALS WAS ALSO INCUBATED) WAS PLACED INTO THE 33-37-DEGREE CELSIUS INCUBATOR; AND ONE PANTA RECONSTITUTED WITH SUPPLEMENT (THE REMAINING SUPPLEMENT IN THE SUPPLEMENT VIALS WAS ALSO INCUBATED). AT THE END OF A 14-DAY INCUBATION PERIOD THERE WAS NO MICROBIAL GROWTH OBSERVED IN 4/4 INCUBATED RETENTION VIALS. FOUR PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS AN UNCRIMPED RECONSTITUTED PANTA VIAL THE STOPPER IS STILL IN THE VIAL, THERE IS POSSIBLE FUNGAL GROWTH IN THE MEDIA. THE SECOND AND THIRD PHOTOS SHOW AN UNCRIMPED RECONSTITUTED PANTA VIAL FROM BATCH 2161204 AND A UNCRIMPED GROWTH SUPPLEMENT VIAL FROM BATCH 2161258 THE SUPPLEMENT VIAL APPEARS TO HAVE BEEN USED. THERE DOES APPEAR TO BE FUNGAL GROWTH IN THE RECONSTITUTED PANTA VIAL. THE LAST PHOTO SHOWS THE LABEL OF A PARTIAL CLOSED KIT CARTON FROM BATCH 2161308. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS RECEIVED. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT WAS CONTAMINATED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: CONTAMINATED OADC VIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT WAS CONTAMINATED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: CONTAMINATED OADC VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604320 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB LEE LABORATORIES, INC. 245124 2161308 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown