BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART SET INFUSION SET

    MDR report key: 1062432 · Received May 31, 2008

    Report

    Report Number
    1062432
    Event Type
    Malfunction
    Date Received
    May 31, 2008
    Date of Event
    May 17, 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 FOUND THE PATIENT IN BED WITH THE LUER LOCK CONNECTOR CONNECTED TO THE PICC LINE. THE IV TUBING WAS BROKEN OFF WITH THE LUER LOCK LYING IN THE BED AND THE PATIENT BLEEDING THROUGH THE PICC LINE. THIS WAS QUICKLY REPLACED. NO PATIENT HARM.

    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 57 YR