BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100%SILICONE 2WAY 5CC 16FR

    MDR report key: 4791393 · Received May 21, 2015

    Report

    Report Number
    8040412-2015-00093
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    March 1, 2015
    Report Date
    April 27, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EZL
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS

    Description of Event or Problem · 1

    ALLEGED EVENT: IT WAS REPORTED THAT THE CUSTOMER HAS REGULARLY ENCOUNTERED A HOLE AT THE MOUTH OF THE CONNECTION PIECE OF THE COLLECTION BAG. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331698 100%SILICONE 2WAY 5CC 16FR FOLEY CATHETER EZL TELEFLEX MEDICAL 14KE47

    Patients

    Seq Age Sex Outcome Treatment
    1