BEUDAMED
    FDA Adverse Event Summary report: N

    INVISION-PLUS NEUTRAL DISPLACEMENT I.V. CONNECTOR

    MDR report key: 743451 · Received June 15, 2005

    Report

    Report Number
    MW4003948
    Date Received
    June 15, 2005
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    MO
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN WAS TEACHING A NEW HOME INFUSION PT HOW TO HOOK UP ANDDISCONNECT HIS MEDICATION. SHE WAS USING A NEW NEUTRAL DISPLACEMENT IV CONNECTOR CALLED THE INVISION PLUS -- UPON DISCONNECTION OF THE TUBING FROM THE CONNECTOR IT WAS NOTED THAT A SMALL DIAMOND SHAPED PIECE OF PLASTIC FROM THE CONNECTOR WAS LEFT IN THE IV TUBING AND COULD EASILY FLOW INTO THE PT THRU THEIR IV CATHETER. THE RN NOTIFIED HER SUPERVISOR AND THE SAME PROCESS WAS DUPLICATED WITH 5 OTHER CAPS IN THE OFFICE. ALL OF THE OTHER CAPS ALSO DID THE SAME THING -- IT APPEARS THAT THE IV TUBING ACTUALLY CORES OUT A PIECE OF PLASTIC FROM THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISION-PLUS NEUTRAL DISPLACEMENT I.V. CONNECTOR RYM - 3000 FPA RYMED TECHNOLOGIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR