BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA PICC WITH PASV

    MDR report key: 5758333 · Received June 29, 2016

    Report

    Report Number
    5758333
    Event Type
    Malfunction
    Date Received
    June 29, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 19, 2016
    Manufacturer
    NAVILYST MEDICAL, INC., AN ANGIODYAMICS COMPANY
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PICC LINE WAS KINKED BY WINGS AND HUB. IT WAS NOT USED ON A PATIENT, WE RECOGNIZED FIRST. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414639 XCELA PICC WITH PASV CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS NAVILYST MEDICAL, INC., AN ANGIODYAMICS COMPANY 497940

    Patients

    Seq Age Sex Outcome Treatment
    1 NO