BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 24904195 · Received April 16, 2026

    Report

    Report Number
    1710034-2026-00424
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 27, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: COMPLAINT REVIEWED AND ANNEX A CODE WAS CHANGED. UPDATED IN IMDRF ANNEX A GRID (1).

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE RETRACTION BUTTON DID NOT WORK. DURING THE IV INSERTION, IT WAS OBSERVED THAT THE SAFETY BUTTON WAS NON-FUNCTIONAL. DAMAGE OR INJURY PRESENTED TO THE PATIENT: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67297 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5149284 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female