BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA

    MDR report key: 2935884 · Received January 28, 2013

    Report

    Report Number
    2935884
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 16, 2012
    Report Date
    January 28, 2013
    Manufacturer
    NAVILYST MEDICAL, INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THERE WAS A LEAK AT THE CONNECTION BETWEEN IV LINE AND PICC DURING INFUSION. THERE'S A CRACK IN THE ORANGE LUMEN. THIS PICC WAS REMOVED AND ANOTHER HAD TO BE PLACED.======================MANUFACTURER RESPONSE FOR PICC, XCELA (PER SITE REPORTER).======================THEY WOULD LIKE TO ANALYZE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38022 XCELA CATHETER LJS NAVILYST MEDICAL, INC * 4415284

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NO OTHER THERAPIES