BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2250869 · Received September 7, 2011

    Report

    Report Number
    2250869
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    April 19, 2011
    Report Date
    September 7, 2011
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN RADIOLOGY DEPARTMENT FOR A CHEST CT SCAN FOR UNRESOLVED PNEUMONIA. PATIENT HAD A PICC LINE PLACED IN THE RIGHT ANTECUBITAL. THE LINE FLUSHED WELL WITH BLOOD RETURN. AT 200CC INTO THE INJECTION, THE PROXIMAL TIP OF THE PICC LINE SPLIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR OTHER