BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL PASV PICC

    MDR report key: 1081149 · Received July 11, 2008

    Report

    Report Number
    1081149
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    July 6, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 5F DUAL LUMEN PICC CATHETER DID NOT FIT INTO THE 5F INTRODUCER. HAD TO REPLACE IT WITH A 4F PICC CATHETER TO FIT THROUGH THE INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PASV PICC CATHETER, PICC LJS BOSTON SCIENTIFIC M001454700 1264326

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES| NO OTHER THERAPIES