BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE 2FR PICC CATHETER

    MDR report key: 2781833 · Received September 27, 2012

    Report

    Report Number
    2781833
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    March 21, 2012
    Report Date
    September 27, 2012
    Manufacturer
    VYGON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED A BAND OF INDURATION FROM .5CM ABOVE PICC INSERTION SITE TO ABOVE THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUTRILINE 2FR PICC CATHETER CATHETER, PICC FOZ VYGON * 1187919

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DAY