BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23656011 · Received November 26, 2025

    Report

    Report Number
    1710034-2025-01876
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 10, 2025
    Report Date
    January 22, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826230
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. YOUR REPORT OF COMPLICATIONS DURING THE INSERTION PROCESS COULD NOT BE CONFIRMED. SEVEN 22G INSYTE AUTOGUARD DEVICES WERE PROVIDED FOR INVESTIGATION. TWO UNITS WERE FROM LOT NUMBER 4080058 AND FIVE UNITS WERE FROM LOT NUMBER 5188475. A FUNCTIONAL TEST TO SIMULATE IV CATHETER INSERTION REVEALED THAT THE NEEDLE TIP PENETRATION, CATHETER TIP PENETRATION, AND CATHETER DRAG FORCES WERE WITHIN SPECIFICATION. A TEST TO LOOSEN THE CATHETER FROM THE NEEDLE AND RETRACT THE NEEDLE WITHIN THE SAFETY SHIELD REVEALED NO DAMAGE OR DEFECTS. THE NEEDLES FULLY RETRACTED AND THE RETRACTION TIME WAS WITHIN SPECIFICATION. A LEAK TEST REVEALED NO LEAKS IN THE RETURNED SAMPLES. THE AFFECTED UNITS WERE NOT RETURNED FOR INVESTIGATION.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

    IN SUCCESSFUL IV STICK: SHREDDED CANNULA. SERIOUS INJURY? NO.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148578 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5188475 00382903826230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown