BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25244552 · Received May 21, 2026

    Report

    Report Number
    1710034-2026-00548
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. (B)(6) 2026. INJURY: PATIENT VEIN BLEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162211 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5148223 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1