BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION PLUS

    MDR report key: 789777 · Received November 30, 2006

    Report

    Report Number
    789777
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Date of Event
    November 21, 2006
    Report Date
    November 30, 2006
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A PICC LINE UTILIZING THE GREEN NEUTRAL IV CONNECTOR CAP. UPON ENTERING THE PT'S ROOM RN FOUND THE IV TUBING HAD BEEN DISCONNECTED AND THE IV CONNECTOR HAD A CRACK IN THE OUTER SHELL. BLOOD HAD FLOWED OUT OF THE PICC LINE THROUGH THE MALFUNCTIONED CRACKED PORT. NEUTRAL IV CONNECTOR WAS DISCONNECTED AND REPLACED. BLOOD WITHDRAWN FROM PICC AND ABLE TO FLUSH PORT. NEW TUBING APPLIED WITH NEW CAP. NO INJURY TO PATIENT. THE FACILITY HAS HAD SIX OCCURRENCES WITH THIS PRODUCT IN THE LAST YEAR. THE COMPANY HAS HAD A PROBLEM WITH A "WELD" EARLIER THIS YEAR. THE MFR HAS COME TO THE SITE AND HAS EXCHANGED THE PRODUCT. THE SITE HAS RECEIVED FOLLOW-UP LETTERS THAT INDICATE THAT THE ISSUES ARE DUE TO "WELD FAILURES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISION PLUS CONNECTOR, IV FPA RYMED TECHNOLOGIES, INC. RYM-5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *