BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA PICC W/PASV VALVE-DUAL LUMEN

    MDR report key: 2073079 · Received April 21, 2011

    Report

    Report Number
    2073079
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    February 3, 2011
    Report Date
    April 13, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PICC LINE PLACED FOR ANTIBIOTIC THERAPY. THIRTEEN DAYS LATER STAFF NOTICED CRACK IN TUBING AT THE HUB. PICC LINE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCELA PICC W/PASV VALVE-DUAL LUMEN PICC, CATHETER LJS NAVILYST MEDICAL UNK 407947

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR