BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW RADIAL ARTERIAL CATHETERIZATION SET

    MDR report key: 24146735 · Received January 22, 2026

    Report

    Report Number
    MW5182638
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    December 31, 2025
    Report Date
    January 16, 2026
    Manufacturer
    ARROW INTERNATIONAL, LLC / TELEFLEX LLC (NADC)
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE ATTEMPTING TO PLACE ARTERIAL LINE, THE CATHETER FRACTURED AND THE TIP WAS NO LONGER VISIBLE AT THE SKIN, YET THE GUIDEWIRE WAS STILL IN PLACE. PEDIATRIC SURGERY WAS CONSULTED TO SURGICALLY REMOVE THE FOREIGN BODY FROM THE PATIENT'S FOREARM. VASCULAR DOPPLER WAS USED AND PATIENT WAS FOUND TO HAVE A TRIPHASIC RADIAL PULSE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215574 ARROW RADIAL ARTERIAL CATHETERIZATION SET ARROW RADIAL ARTERIAL CATHETERIZATION SET DQX ARROW INTERNATIONAL, LLC / TELEFLEX LLC (NADC) 14F25B0032

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Required Intervention