BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRUITT F3 SHUNT

    MDR report key: 2445019 · Received January 31, 2012

    Report

    Report Number
    2445019
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 31, 2012
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBING LEAKS AT CONNECTION BETWEEN BLUE TUBING AND 2 WAY PORT. THIS DEVICE WAS NOT USED ON THE PATIENT.======================MANUFACTURER RESPONSE FOR PRUITT F3 CAROTID SHUNT, PRUITT F3 SHUNT (PER SITE REPORTER).======================REPRESENTATIVE WILL TAKE PRODUCT ON WEDNESDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT F3 SHUNT PRUITT F3 CAROTID SHUNT MJN LEMAITRE VASCULAR, INC. +SS0814PFT2260C PFT2260

    Patients

    Seq Age Sex Outcome Treatment
    1 *