BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW-HOWES LARGE-BORE MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT

    MDR report key: 2182335 · Received July 25, 2011

    Report

    Report Number
    MW5021517
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 31, 2010
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLACED GUIDE WIRE INTO SUBCLAVIAN TO A POINT THAT IT STOPPED. HAD DIFFICULTY GETTING IT REMOVED. WHEN REMOVED, THE WIRE HAD FOUR KINKS IN IT. CENTRAL LINE WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW-HOWES LARGE-BORE MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT CENTRAL VENOUS CATHETERIZATION KIT DQO ARROW INTERNATIONAL, INC. AK-22123 RF0018220

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention