BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20684059 · Received November 14, 2024

    Report

    Report Number
    1710034-2024-01339
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 29, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED FIVE SEALED 20GA X 1.00IN. INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 4222726. ALL 5 UNITS WERE INSPECTED BY BREAKING TIP ADHESION, SLIGHTLY ADVANCING CATHETER, AND THEN ACTIVATING THE BUTTON. EACH UNIT RETRACTED SUCCESSFULLY WITH NO DEFECTS DISCOVERED. A VISUAL INSPECTION DID NOT DISCOVER ANYTHING THAT COULD INDICATE POTENTIAL RETRACTION DIFFICULTIES. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: CUSTOMER DOESN'T FEEL CONFIDENT ON UTILIZING THESE FOR THE OFF HAND CHANCE THEY MAY MALFUNCTION. THE COMMON PROBLEM I AM SEEING IS THE BUTTON WON'T RELEASE TO PULL THE NEEDLE BACK INTO THE CHAMBER AND THREAD THE CATHETER¿ABOUT 15% OF THE STOCK PER BOX SEEMS TO BE AFFECTED BUT THEY DON¿T KNOW WHICH IN A BOX HAS THE ISSUE. INJURIES OR ADVERSE EVENT: NO. I¿M SORRY. I DO NOT HAVE EXACT DATES, BUT I KNOW IT HAS HAPPENED ON MULTIPLE OCCASIONS WITH SEVERAL OF MY EMPLOYEES OVER THE 90 DAYS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223461 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4222726 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown