BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICTH VSYS/PRT/LCK 4NDL LWPF

    MDR report key: 1081722 · Received July 25, 2008

    Report

    Report Number
    1219930-2008-00558
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    May 30, 2008
    Report Date
    July 14, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    LJT
    PMA / PMN Number
    K952748
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THERE IS A VERTICAL BREAK ON THE CATHETER WHERE IT'S NEAR TO THE PORT CONNECTOR. THIS PROBLEM WAS FOUND OUT AFTER THE PORT IS IMPLANTED FOR SEVERAL WEEKS AND THE DR EXPERIENCED A PROBLEM INJECTING THE SOLUTION. PRODUCT WAS EXPLANTED AND REPLACED WITH A NEW PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICTH VSYS/PRT/LCK 4NDL LWPF NONE LJT NORTH HAVEN - USS N7L183

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention