BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD

    MDR report key: 25184569 · Received May 15, 2026

    Report

    Report Number
    1710034-2026-00516
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 22, 2026
    Report Date
    April 29, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814114
    PMA / PMN Number
    SEE H.11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. ATTEMPTS TO CLARIFY ADVERSE PATIENT OUTCOME WERE UNSUCCESSFUL. CUSTOMER DID NOT RESPOND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB HAD A SHARPNESS. "CUSTOMER PLACED 24 X 0.75 PIVC IN XXX PATIENT - CORRECT PROCESS AND PROCEDURE WAS FOLLOWED. CUSTOMER MENTIONED THAT THERE WAS A PRESSURE WOUND FROM BD PIVC AS THERE WAS A SHARPNESS ON THE CATHETER HUB.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221742 INSYTE-N AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5280605 00382903814114

    Patients

    Seq Age Sex Outcome Treatment
    1