BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW INTERNATIONAL INC

    MDR report key: 2619248 · Received October 2, 2009

    Report

    Report Number
    2619248
    Event Type
    Malfunction
    Date Received
    October 2, 2009
    Date of Event
    October 14, 2009
    Report Date
    October 14, 2009
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COULD NOT ADVANCE CATHETER INTO ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL INC RADIAL ARTERY CATH SET DQY CF8048174

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR