BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2973589 · Received February 15, 2013

    Report

    Report Number
    2973589
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HICKMAN 7 FR DUAL LUMEN CATHETER PLACEMENT UTILIZING "ATRAUMATIC" FORCEPS. PHYSICIAN NOTED THAT A HOLE WAS MADE IN THE CATHETER LINE BY THE "ATRAUMATIC" FORCEPS. CATHETER WAS NOT PLACED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HICKMAN DUAL LUMEN PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69471 * CATHETER, INTRAVASCULAR, THERAPEUTIC LJS BARD ACCESS SYSTEMS INC. * HUWA0676

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR