BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2704627 · Received August 14, 2012

    Report

    Report Number
    2704627
    Event Type
    Malfunction
    Date Received
    August 14, 2012
    Date of Event
    July 10, 2012
    Report Date
    August 14, 2012
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT'S INNER CANNULA TO A #6 SHILEY LPC TRACH TUBE WAS VERY LOOSE. IT ACCIDENTALLY BECAME DISLODGED, THEREFORE PATIENT WAS DISCONNECTED FROM SUPPORT. THIS HAS BEEN A RECURRING ISSUE WITH SHILEY LPC TRACHS. THE COVIDIEN, TYCO HEALTHCARE, SHILEY 6LPC (LOT NUMBER IS UNKNOWN, AS THE DEVICE WAS DISCARDED AND NOT GIVEN TO BIOMED). HOSPITAL IS CONSIDERING SWITCHING TO THE DCT MODEL, AS THE TABS ON THE LPC MAY BE WEARING OVER TIME BY UNSCREWING THE INNER CANNULA AND CLEANING IT DURING TRACH CARE.======================MANUFACTURER RESPONSE FOR TUBE,TRACHEOSTOMY, SHILEY (PER SITE REPORTER).======================SALES REPRESENTATIVE RECOMMENDS SWITCHING TO THE DCT MODEL, AS HE SAYS THE LPC MODEL IS MORE FOR HOME USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TUBE, TRACHEOSTOMY JOH COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *