BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT

    MDR report key: 6431740 · Received March 24, 2017

    Report

    Report Number
    6431740
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    February 26, 2017
    Report Date
    March 1, 2017
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT OF A PEDIATRIC INTENSIVE CARE PATIENT, AN ATTEMPT TO SUCTION THROUGH A 3.0 MM ENDOTRACHEAL TUBE (ETT) WAS PERFORMED WITH AN 8 F CLOSED SUCTION SYSTEM. IT HAD BEEN FOUND THAT THE SECRETIONS WERE TOO THICK FOR SUCTIONING WITH A 6 F CATHETER. WHILE THE 8 F CLOSED SUCTION SYSTEM PACKAGING INDICATED THAT ITS CONTENTS INCLUDED AN ADAPTER FOR A 3.0 MM ETT, IT WAS NOT POSSIBLE TO PASS THE SUCTION CATHETER THROUGH THE ENTIRE ETT. THE INABILITY TO SUCTION THIS PATIENT RESULTED IN A DROP IN SPO2 AND REQUIRED REMOVAL OF THE ETT. MANUFACTURER RESPONSE FOR 3.0 MM ENDOTRACHEAL TUBE, KIMVENT (PER SITE REPORTER): THE MANUFACTURER HASN'T HAD TIME TO INVESTIGATE THE REPORTED PROBLEM. MANUFACTURER RESPONSE FOR CLOSED SUCTION SYSTEM, KIMVENT (PER SITE REPORTER): THE MANUFACTURER HASN'T HAD TIME TO INVESTIGATE THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213332 KIMVENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR HALYARD HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other N.A.