BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC KIT: 3-LUMEN 5.5 FR X 13 CM

    MDR report key: 1192263 · Received September 26, 2008

    Report

    Report Number
    1192263
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFO WAS REC'D BY MEDWATCH REPORT. IT WAS REPORTED THAT DURING WITHDRAWAL OF THE GUIDEWIRE ON CENTRAL VENOUS PRESSURE (CVP) PLACEMENT, GUIDEWIRE BEGAN TO FRAY AND FALL APART. GUIDEWIRE WAS CUT LEAVING THE GUIDEWIRE IN THE VENTRICLE OF THE HEART. IT WAS RETRIEVED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 5.5 FR X 13 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL., INC. * RF8029575

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention