BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 1022941 · Received March 28, 2008

    Report

    Report Number
    2936999-2008-00147
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HE
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN HAS REQUESTED THE SHILEY SCT TRACHEOSTOMY TUBE BE RETURNED FOR FAILURE INVESTIGATION. THE COMPLAINT INVESTIGATION IS CURRENTLY IN PROGRESS. THE HISTORY RECORDS FOR THIS LOT WILL BE REVIEWED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT A SCT SPECIALIZED TRACHEOSTOMY TUBE WITH THE WRONG CURVATURE WAS PLACED IN A PT. AT THREE DAYS OF USE THE PT REPORTED SEVERE DISCOMFORT TO THE MEDICAL DISTRIBUTOR. THE TUBE REMAINED IN THE PT FOR ANOTHER 7 DAYS WHILE ANOTHER TUBE WAS ACQUIRED. ONCE THE REPLACEMENT TUBE WAS RECEIVED, THE PT WAS DECANULATED AND THEN RECANULATED WITH THE NEW TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE BTO COVIDIEN/FORMERLY TYCO HE SCT 0801001647

    Patients

    Seq Age Sex Outcome Treatment
    1