BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25339981 · Received May 29, 2026

    Report

    Report Number
    1710034-2026-00564
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, IL WAS USED AS THE STATE.

    Description of Event or Problem · 0

    "TO CLARIFY THE ISSUE, AFTER I INSERTED THE CATHETER AND REMOVED THE NEEDLE, THE SAFETY BUTTON APPEARED TO BE STUCK. THIS PREVENTED THE NEEDLE FROM RETRACTING FULLY INTO THE SAFETY HOUSING AS INTENDED." ADDITIONAL INFORMATION: THE EVENT OCCURRED ON 05/05/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592299 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5328821 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1