BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISION-PLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 5675311 · Received May 20, 2016

    Report

    Report Number
    MW5062434
    Event Type
    Injury
    Date Received
    May 20, 2016
    Date of Event
    May 3, 2016
    Report Date
    May 16, 2019
    Manufacturer
    RYMED TECHNOLOGIES, LLC
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEEDLESS CONNECTOR ON A CENTRAL LINE WAS FOUND TO BE BROKEN INTO TWO PIECES. THERE WAS A SHARP GREEN PORTION THAT HAD DETACHED FROM THE CLEAR CAP. THE MAINTENANCE IV FLUIDS AND VASOPRESSOR WAS INFUSING INTO THE PILLOW. THE PATIENT'S PORT TO THE CENTRAL VENOUS LINE WAS OPEN TO THE AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325244 INVISION-PLUS CLEAR NEEDLELESS CONNECTOR INVISION NEEDLE-LESS CONNECTOR FPA RYMED TECHNOLOGIES, LLC M00142

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention