BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 2973849 · Received February 14, 2013

    Report

    Report Number
    MW5029026
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 14, 2013
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS INSERTED INTO PT. UPON REMOVING THE STYLET OR GUIDE WIRE, THERE WAS RESISTANCE ENTIRE PRODUCT WAS THEN REMOVED. THE TIP OF THE CANNULA SEEMED TO BE KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66298 ARROW RADIAL ARTERY CATHETERIZATION SET DQX ARROW INTERNATIONAL, INC. RA-04020 CF2067832

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR