BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION-PLUS

    MDR report key: 6268072 · Received January 20, 2017

    Report

    Report Number
    3005951712-2017-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Report Date
    January 20, 2017
    Manufacturer
    RYMED TECHNOLOGIES, LLC
    Product Code
    FPA
    PMA / PMN Number
    K991653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 1/6/2017, IT WAS REPORTED BY THE USER FACILITY THAT THEY HAD AN ISSUE WITH ONE (1) INVISION-PLUS IV CONNECTOR. THE REPORT FROM THE FACILITY STATED: "THE NURSE FOUND THE GREEN PART ATTACHED TO THE PICC BUT THE WHITE PART WAS MISSING. AFTER A LOT OF SEARCHING, THE WHITE PART WAS FOUND IN THE BED. THIS IS AN ISOLATED INCIDENT, AS FAR AS I KNOW, I HAVEN'T HEARD OF ANY OTHERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49566 INVISION-PLUS NEEDLELESS IV CONNECTOR FPA RYMED TECHNOLOGIES, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1