BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA FLEXTEND

    MDR report key: 3042215 · Received March 27, 2013

    Report

    Report Number
    3042215
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 27, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR DEPENDENT CHILD WAS GIVEN NEW TYPE OF TRACHEOSTOMY TUBE - COINCIDENT WITH THIS, THE PATIENT DEVELOPED SIGNIFICANT RESPIRATORY DISTRESS, WITH WHEEZING, POOR VENTILATION DESPITE THE VENTILATOR. OVER THE COURSE OF THE NEXT TWO WEEKS, THE CHILD WAS TRANSFERRED TO THE ICU 3 TIMES AND HOSPITAL DISCHARGE WAS DELAYED AT LEAST TWO WEEKS. FLEXIBLE BRONCHOSCOPY WAS DONE, REVEALING THAT THE TIP OF THE TUBE WAS BURROWED INTO THE TRACHEAL MUCOSA. A CUSTOM TUBE OF A LONGER LENGTH WAS ORDERED, AND WHEN PLACED IT BECAME CLEAR THAT THE DESIGN OF THE TUBE MADE IT INEVITABLE AND INESCAPABLE THAT THE TIP OF THE TUBE WOULD IMPACT ONTO THE ANTERIOR TRACHEAL WALL.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PROVISION OF A SAFE AND ADEQUATE AIRWAY IN A CHILD.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125069 BIVONA FLEXTEND TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *