BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 18367305 · Received December 20, 2023

    Report

    Report Number
    1025402-2023-00047
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 29, 2023
    Report Date
    April 3, 2024
    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

    H.6. INVESTIGATION SUMMARY: THE COMPONENTS OF KIT BATCH 3180624 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 PANTA BATCH 3180592 (10 VIALS). THERE WERE NO FOREIGN MATERIALS OBSERVED IN 10/10 RETENTION SAMPLES INSPECTED. SUPPLEMENT RETENTIONS WERE NOT AVAILABLE FOR INSPECTION. FOR FURTHER INVESTIGATION TWO PANTA VIALS FROM BATCH 3180592 WERE RECONSTITUTED WITH 3ML OF STERILE WATER. ONE PANTA VIAL RECONSTITUTED WITH 3ML STERILE WATER WAS PLACED INTO 20-25-DEGREES CELSIUS INCUBATOR; AND ONE PANTA VIAL RECONSTITUTED WITH 3ML STERILE WATER WAS PLACED INTO 33-37-DEGREES CELSIUS INCUBATOR. AT THE END OF A 14-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 INCUBATED RETENTION VIALS. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION. THE PHOTO SHOWS ONE VIAL OF RECONSTITUTED PANTA WITH GROWTH IN THE VIAL, BATCH 3145445 EXP 2024-11-17. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. THE PHOTO DOES NOT VERIFY THE BATCH FOR THIS COMPLAINT. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION DEFECTS.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT HAD FOREIGN MATTER INSIDE. NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT HAD FOREIGN MATTER INSIDE. NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163783 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB LEE LABORATORIES, INC. 3180624 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown