BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE INFUSION SET

    MDR report key: 1251404 · Received November 24, 2008

    Report

    Report Number
    1251404
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 24, 2008
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THERE WAS A HOLE IN THE IV TUBING THAT WAS LEAKING NOTICEABLY. THE INFUSION WAS STOPPED AND THE TUBING WAS REPLACED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE INFUSION SET TUBING, IV FPA CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES 2420-0007 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR