BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY IV INFUSION SET

    MDR report key: 1273942 · Received December 15, 2008

    Report

    Report Number
    1273942
    Event Type
    Malfunction
    Date Received
    December 15, 2008
    Date of Event
    November 22, 2008
    Report Date
    December 15, 2008
    Manufacturer
    CARDINAL HEALTH, MEDICAL PRODUCTS & SERVICES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON INSPECTION OF AN IV LINE SUPPLYING INSULIN DRIP, THE DISTAL MED PORT MEMBRANE HAD BEEN PUSHED INTO THE Y-SITE. THIS CAUSED A COMPLETE OCCLUSION IN THE DISTAL LINE, AND INSULIN WAS LEAKING OUT THE NOW OPEN PORT. THE ADMINISTRATION SET WAS CHANGED AND THE INSULIN WAS RE-HUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY IV INFUSION SET TUBING, IV FPA CARDINAL HEALTH, MEDICAL PRODUCTS & SERVICES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR