BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE

    MDR report key: 248343 · Received September 2, 1999

    Report

    Report Number
    2029387-1999-00113
    Event Type
    Malfunction
    Date Received
    September 2, 1999
    Date of Event
    May 1, 1999
    Report Date
    July 31, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA INTERNATIONAL MALLINCKRODT FACILITY THAT A PT INTUBED WITH A SIZE 6 FEN, FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE EXPERIENCED PROBLEMS WHEN THE 15MM CONNECTOR ON THE INNER CANNULA BECAME LOOSE. THE INFORMATION RECEIVED INDICATED THE CONNECTOR "WAS SWIVELING INDEPENDENTLY." THE DEVICE WAS IN USE APPROXIMATELY TWO (2) TO THREE (3) DAYS WHEN THE PROBLEM OCCURRED. THERE WAS ONE (1) PT INVOLVED WITH NO REPORTED PT INJURY. ONLY THE INNER CANNULA COMPONENT WAS RETURNED TO THE MANUFACTURER FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION ON 05/25/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6 FEN M81911000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN