BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION PLUS

    MDR report key: 837262 · Received March 12, 2007

    Report

    Report Number
    837262
    Event Type
    Malfunction
    Date Received
    March 12, 2007
    Date of Event
    February 13, 2007
    Report Date
    March 12, 2007
    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

    REPORTING RN (ALSO ICU MATERIALS CONTACT) RETURNED FROM VACATION TO FIND BROKEN RYMED INVISION-PLUS IV CONNECTOR IN HER MAILBOX. REPORTING RN HAS BEEN UNABLE TO DETERMINE WHO PLACED BROKEN PRODUCT IN HER BOX BUT REPORTED THE INCIDENT AS IT IS CLEAR THAT THREADS BROKE AND CRACKED ON PRODUCT. KNOWING WE'VE HAD OTHER ISSUES WITH THIS DEVICE SHE FELT MANUFACTURER WOULD MORE THAN LIKELY APPRECIATE PRODUCT BE RETURNED FOR EVALUATION PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISION PLUS CONNECTOR, IV, NEEDLESS FPA RYMED TECHNOLOGIES, INC. RYM-5000 CURRENTLY USING LOT 415 IN ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 *