BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL ARTERY CATHETERIZATION SET

    MDR report key: 11893165 · Received May 26, 2021

    Report

    Report Number
    MW5101566
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 22, 2021
    Report Date
    May 25, 2021
    Manufacturer
    ARROW INTERNATIONAL, LLC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CABG ARTERIAL CATHETER NEEDLE BROKE WHILE INSERTED IN PATIENT. REMOVAL OF CATHETER/NEEDLE UPON DISCOVERY OF BROKEN MATERIAL. PROVIDER REQUESTED FOR BROKEN ARTERIAL CATHETER/NEEDLE SENT TO MANUFACTURER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786445 RADIAL ARTERY CATHETERIZATION SET WIRE, GUIDE, CATHETER DQX ARROW INTERNATIONAL, LLC 14F20D0034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention