BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOTLINE

    MDR report key: 1627812 · Received March 1, 2010

    Report

    Report Number
    1627812
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 25, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN DISCONNECTING FLUID WARMING SET FROM EXTENSION TUBING, THE END OF THE TUBING CRACKED AND BROKE OFF IN THE EXTENSION TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOTLINE IV FLUID WARMING SET, LEVEL 1 LGZ SMITHS MEDICAL L-70 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *