BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25150357 · Received May 12, 2026

    Report

    Report Number
    1710034-2026-00505
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 21, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE CAUGHT ON THE CATHETER. "ATTEMPTED TO INITIATE IV ACCESS W8TY AH 18G BD IV CATHETER. THE IV CATHETER WAS ADVANCED HALFWAY UP THE NEEDLE WHEN THE RN CLICKED THE BUTTON TO ACTIVATE THE RETRACT MECHANISM. AS THE NEEDLE RETRACTED, IT GRABBED THE CATHETER AND PULLED IT OUT OF THE PATIENTS ARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195642 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5045783 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1