BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL ARTERY CATHETERIZATION SET

    MDR report key: 2110053 · Received May 20, 2011

    Report

    Report Number
    2110053
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL FROM THE VESSEL, THE WIRE GUIDE TIP FRAYED, CAUSING THE PATIENT PAIN IN HER ARM FROM HER HAND TO HER SHOULDER. ULTRASOUND WAS NOT USED IN THE WIRE'S PLACEMENT. IT IS UNCLEAR WHETHER THIS IS A USE ERROR OR A PRODUCT PROBLEM, AND ARROW IS WORKING WITH US TO DETERMINE IF ADDITIONAL EDUCATION IS NEEDED.======================MANUFACTURER RESPONSE FOR RADIAL ARTERY CATHETERIZATION SET:(PER SITE REPORTER) FIRM IS WORKING WITH US TO DETERMINE IF ADDITIONAL EDUCATION IS NEEDED WITH RESPECT TO PLACEMENT. WE HAVE A SAMPLE FROM THE SAME LOT THAT WE WILL RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL ARTERY CATHETERIZATION SET CATHETER, PERCUTANEOUS, RADIAL ARTERY CATHETERIZATION SET DQY ARROW INTERNATIONAL * CF9110163

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR