BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD ACCESS SYSTEMS, INC.

    MDR report key: 1734522 · Received June 18, 2010

    Report

    Report Number
    MW5016454
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 18, 2010
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PICC INSERTION RESULTED IN THE TIP OF THE GUIDEWIRE BREAKING OFF. THIS RESULTED IN THE TIP BEING RETRIEVED THROUGH INTERVENTIONAL RADIOLOGY. DIAGNOSIS OR REASON FOR USE: PICC LINE NEEDED FOR IV MEDICATION ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEMS, INC. POWERPICC POLYURETHANE PICC LJS BARD ACCESS SYSTEMS, INC. REUC1135

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other