BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2010864 · Received February 24, 2011

    Report

    Report Number
    2010864
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ICU MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS STARTING IV WHEN IV EXTENSION TUBING LUER LOCK HUB FOUND TO BE STUCK OPEN. UNABLE TO SECURE TUBING TO CATHETER HUB, BECAUSE THE SCREW CAP WOULD NOT MOVE. HAD TO EXCHANGE TUBING WHILE MAINTAINING IV CATHETER IN PLACE. NURSE HAD TO CALL FOR ASSISTANCE IN ORDER TO AVOID RESTICKING THE PATIENT. IV WAS OPEN TO AIR FOR PROLONGED PERIOD DUE TO TUBING DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INTRAVASCULAR TUBING, CONNECTOR FPA ICU MEDICAL * 91-328-R5 (NOT CERTAIN)

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR