BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRUITT F3

    MDR report key: 2820200 · Received October 15, 2012

    Report

    Report Number
    2820200
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 15, 2012
    Manufacturer
    LEMAITRE VASCULAR, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE 5CC SYRINGE ATTACHED TO THE RED LINE LOOSELY AND KEPT FALLING OFF. THIS PROBLEM HAS PREVIOUSLY OCCURRED WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT F3 CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY FPA LEMAITRE VASCULAR, INC 2012-10 PFT2335

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR