BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSURETHRAL CATHETER

    MDR report key: 4780535 · Received May 18, 2015

    Report

    Report Number
    8040412-2015-00106
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 6, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EZL
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WATER SPRAYED OUT FROM THE LEAKING BALLOON AFTER 5 MLS OF WATER WAS INJECTED INTO THE BALLOON OF THE CATHETER. A SECOND CATHETER WAS USED SUCCESSFULLY. NO PT INJURY REPORTED. PT CURRENT CONDITION REPORTED AS FINE. THIS PRODUCT IS SOLD IN THE US AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322724 TRANSURETHRAL CATHETER CATHETER EZL TELEFLEX MEDICAL 13CT46

    Patients

    Seq Age Sex Outcome Treatment
    1