BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT:2-LUMEN 7 FR X 20 CM

    MDR report key: 1231864 · Received August 1, 2008

    Report

    Report Number
    1231864
    Event Type
    Malfunction
    Date Received
    August 1, 2008
    Date of Event
    June 23, 2008
    Report Date
    August 1, 2008
    Manufacturer
    ARROW INTL INC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY MEDWATCH THAT THE PROCEDURE WAS BEING PERFORMED ON A FEMALE PT. ON THE EVENT DATE, THE CENTRAL VENOUS PRESSURE (CVP) LINE WAS INSERTED BY THE ANESTHESIOLOGIST AND THE GUIDEWIRE WAS LEFT INSIDE THE LUMEN. INTENSIVIST REMOVED CVP LINE WITHOUT ADVERSE CONSEQUENCES TWO DAYS LATER. PT WAS DISCHARGED STABLE. USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT:2-LUMEN 7 FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL INC * RF8018272

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR