BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25069918 · Received May 4, 2026

    Report

    Report Number
    1710034-2026-00491
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 22, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 DID NOT RETRACT. ONE NEEDLE WOULDN'T T RETRACT. INJURIES/ADVERSE EVENTS: NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148562 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1