BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFUSE

    MDR report key: 6912909 · Received October 3, 2017

    Report

    Report Number
    2025816-2017-00214
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    August 10, 2017
    Report Date
    October 3, 2017
    Manufacturer
    ICU MEDICAL
    Product Code
    FMG
    UDI-DI
    00887709036512
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE NURSE OBSERVED A PIECE STICKING OUT OF THE CLAVE OF THE SMALLBORE TRIFUSE EXT SET. UPON PICC LINE ASSESSMENT, THE NURSE NOTED THAT CLAVE CLOSEST TO THE PATIENT HAD THE INSIDE PART PROTRUDING OUT WITHOUT ANY LEAKING TO BE EVIDENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE WAS NOT RETURNED, THEREFORE NO TESTING OF THE ACTUAL DEVICE COULD OCCUR. A TWO-YEAR REVIEW OF THE COMPLAINT DATABASE LIST K181-001 WITH SIMILAR PROBLEMS REVEALED NO ADDITIONAL REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692745 TRIFUSE IV ADMIN SET FMG ICU MEDICAL K181-001 UNKNOWN 00887709036512

    Patients

    Seq Age Sex Outcome Treatment
    1