BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR DUAL LUMEN PICC

    MDR report key: 2250816 · Received September 1, 2011

    Report

    Report Number
    2250816
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 28, 2011
    Report Date
    September 1, 2011
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BETWEEN THE SPRING OF THIS YEAR AND LATE SUMMER, TEN PICC LINES ON TEN DIFFERENT PATIENTS HAD TO BE REPLACED BECAUSE THEY HAVE HAD A HOLE AND/OR WERE BROKEN. THESE REPEATED HOLES OR BREAKS HAVE OUR IV SPECIALIST CONCERNED OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR DUAL LUMEN PICC CATHETER, PICC LJS BARD ACCESS SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR