BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW INTERNATIONAL, INC.

    MDR report key: 4994684 · Received June 23, 2015

    Report

    Report Number
    4994684
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 23, 2015
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPROXIMATE 1.5 INCH PORTION OF ARTERIAL LINE CATHETER SHEARED OFF AND WAS RETAINED DURING ATTEMPTED INSERTION, REQUIRING REMOVAL OF FOREIGN BODY AND REPAIR OF RIGHT RADIAL ARTERY BY VASCULAR SURGICAL TEAM. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406658 ARROW INTERNATIONAL, INC. 20 GAUGE ARROW RADIAL ARTERY CATHETER DQY ARROW INTERNATIONAL, INC. 14F15B0313

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R