BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3428849 · Received October 4, 2013

    Report

    Report Number
    3428849
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 4, 2013
    Manufacturer
    ANGIODYNAMICS INC.
    Product Code
    ---
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TWO 4 FR SLIM CATHETERS WERE OPENED FOR USE DURING A CASE. BOTH 4 FR CATHETERS WERE FROM THE SAME LOT NUMBER. ONE KINKED AND ONE BROKE OFF OUT SIDE OF THE BODY DURING THE PROCEDURE. WE THEN HAD TO THEN GO TO A 5 FR SYSTEM. THERE WAS NO HARM TO THE PATIENT. NO DIFFICULTY USING THE 5 FR SYSTEM. THE PHYSICIAN/STAFF BELIEVE THE LOT MAY BE DEFECTIVE. ALL 4 FR CATHETERS FROM THIS LOT WERE PULLED AND WILL BE RETURNED TO THE MANUFACTURER'S REP.====================== MANUFACTURER RESPONSE FOR CATHETER, ANGIO DYNAMICS INC (PER SITE REPORTER).====================== WE ARE GOING TO HAVE THE REP SWAP OUT THE FAILED DEVICES OF THIS LOT NUMBER FOR A NEW LOT NUMBER. THE REP HAS ALREADY SWAPPED OUT THE ONES THAT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504344 * * --- ANGIODYNAMICS INC. * *
    504502 SOFT-VU CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO ANGIODYNAMICS INC. * 591386
    504503 SOFT-VU CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO ANGIODYNAMICS INC. * 591386

    Patients

    Seq Age Sex Outcome Treatment
    1 *