BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY

    MDR report key: 5520215 · Received March 23, 2016

    Report

    Report Number
    2936999-2016-00213
    Event Type
    Death
    Date Received
    March 23, 2016
    Date of Event
    November 20, 2015
    Report Date
    February 22, 2016
    Manufacturer
    COVIDIEN
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC REFERENCE (B)(4). USER FACILITY REFERENCE: MW5059711. THE MODEL OF TUBE WAS NOT PROVIDED. THE 510K CANNOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED. THE DATE OF MANUFACTURE CANNOT BE DETERMINED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE ONGOING.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A USER REPORT IN WHICH THE CUSTOMER STATED THE SIZE 8 CUFFED TRACHEOSTOMY TUBE WAS PLACED IN THE PATIENT (B)(6) 2015. THE TRACHEOSTOMY TUBE'S CUFF WAS LEAKING. AIR WAS LEAKING AROUND THE TRACHEOSTOMY TUBE AND THE PATIENT'S MOUTH. THIS BEGAN TO OCCUR AROUND 17 HOURS AFTER PLACEMENT. THE TUBE WAS REMOVED AND REPLACED. THE PATIENT ARRESTED DURING THE PROCESS AND EXPIRED THE FOLLOWING DAY. THE MODEL OF THE TUBE WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175554 SHILEY TRACHEOSTOMY TUBE BTO COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R