BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMI-PICC INTRODUCER

    MDR report key: 4726037 · Received March 10, 2015

    Report

    Report Number
    4726037
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Date of Event
    January 5, 2015
    Report Date
    January 14, 2015
    Manufacturer
    FOOTPRINT MEDICAL, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US

    Narratives

    Description of Event or Problem · 1

    PICC DISPOSABLE INTRODUCER SEPARATED INTO TWO PIECES WHEN SEPARATING FROM CANNULA. PICC STILL IN PLACE WITH REMAINING INTRODUCER EXTERIOR TO INSERTION SITE. STILL IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163572 FMI-PICC INTRODUCER INTRODUCER, CATHETER DYB FOOTPRINT MEDICAL, INC. 1.9 CM 4466

    Patients

    Seq Age Sex Outcome Treatment
    1 *