BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRAL TIP URETERAL CATHETER

    MDR report key: 1231246 · Received November 3, 2008

    Report

    Report Number
    1231246
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 3, 2008
    Manufacturer
    BARD UROLOGICAL DIVISION
    Product Code
    EYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BARD SPIRAL TIP URETERAL CATHETER SPONTANEOUSLY FRACTURED INTO TWO PIECES DURING A PROCEDURE. THE PIECES WERE REMOVED AND PATIENT WAS NOT ADVERSELY EFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIRAL TIP URETERAL CATHETER CATHETER, URETERAL EYB BARD UROLOGICAL DIVISION SIZE 6 FRENCH RIGHT *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR