BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC

    MDR report key: 3113819 · Received September 20, 2006

    Report

    Report Number
    3113819
    Event Type
    Malfunction
    Date Received
    September 20, 2006
    Date of Event
    September 21, 2006
    Report Date
    September 21, 2006
    Manufacturer
    SMITH MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTED THAT THE INFUSION SET CANNULA BROKE OFF IN HIS LEG AFTER INSERTION. REFERENCE MFR # 2183502-2006-00236.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTEC CLEO 90 FOZ SMITH MEDICAL CLEO 90 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR