BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART SITE

    MDR report key: 515815 · Received February 27, 2004

    Report

    Report Number
    MW1031371
    Event Type
    Malfunction
    Date Received
    February 27, 2004
    Date of Event
    February 26, 2004
    Report Date
    February 27, 2004
    Manufacturer
    *
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ACCESS PIN HAS NO COVER. NURSES ARE EXPRESSING CONCERNS REGARDING THE VIABILITY TO KEEP THE PIN STERILE FOLLOWING REMOVAL FROM THE PACKAGE. THE OLD STYLE 312804 WITH THE NEEDLE HAD A COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART SITE ACCESS PIN NEEDLE-FREE PORT FPA * 2200E 401809

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other