BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT IV PLUS-W SAFETY CATHETER RADIOPAQUE

    MDR report key: 2003534 · Received February 21, 2011

    Report

    Report Number
    MW5019520
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER HAD A SHEARED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECT IV PLUS-W SAFETY CATHETER RADIOPAQUE JELCO 24G, 5/8 INCH FOZ SMITHS MEDICAL 3038 ST1933829

    Patients

    Seq Age Sex Outcome Treatment
    1