BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART SET INFUSION SET

    MDR report key: 1062563 · Received May 31, 2008

    Report

    Report Number
    1062563
    Event Type
    Malfunction
    Date Received
    May 31, 2008
    Date of Event
    April 13, 2008
    Report Date
    May 31, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE WAS SETTING UP THE INFUSION ON THE PATIENT AND ATTACHED THE BAG OF FLUID. SHE THEN NOTICED THAT THERE WAS NO ROLLER CLAMP ON THE IV TUBING. SHE REPLACED THE TUBING; THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART SET INFUSION SET TUBING, IV FPA ALARIS MEDICAL SYSTEMS, INC. 2420--0007 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR