BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYSITE

    MDR report key: 7534306 · Received May 22, 2018

    Report

    Report Number
    7534306
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 25, 2018
    Report Date
    May 2, 2018
    Manufacturer
    ICON CLINICAL RESEARCH
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROVIDER DID NOT CONNECT THE MEDIPORT PIECES TOGETHER CORRECTLY PRIOR TO IMPLANTING THE DEVICE. THE DEVICE THEN CAME APART WITHIN THE PATIENT AND HAD TO BE REMOVED. THIS WAS A USER ERROR ISSUE, NOT TECHNICALLY A DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375003 POLYSITE PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ICON CLINICAL RESEARCH 2016PI 17100189

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other