BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3080101 · Received March 27, 2013

    Report

    Report Number
    3080101
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 27, 2013
    Manufacturer
    COOK, INC
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD 2 CHEST TUBES PLACED IN CT. BOTH CATHETERS WERE ATTACHED TO PLEUR-EVAC WHILE MOVING THE PATIENT OFF THE TABLE A CATHETER MALFUNCTION (THE RIGHT) OCCURRED WITH THE HUB PULLING AWAY FROM THE CATHETER STEM. THE PATIENT WAS PLACED BACK ON THE CT TABLE AND A LIMITED CT PERFORMED. THIS DEMONSTRATED NO SIGNIFICANT PNEUMOTHORAX. THE CATHETER WAS STERILELY CLEANSED AND DRAPED. THIS CATHETER WAS REMOVED OVER A GUIDEWIRE AND REPLACED THE 14 FR CATHETER WHICH WAS SECURED TO THE SKIN WITH SUTURE.======================MANUFACTURER RESPONSE FOR DRAINAGE CATHETER, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127288 * CATHETER DQR COOK, INC * 3493804

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR