BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY CUFFLESS FENESTRATED TRACHEOSTOMY TUBE

    MDR report key: 99056 · Received June 13, 1997

    Report

    Report Number
    2029387-1997-00095
    Event Type
    Malfunction
    Date Received
    June 13, 1997
    Date of Event
    March 1, 1997
    Report Date
    May 8, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA INTERNATIONAL MALLINCKRODT MEDICAL FACILITY (CANADA) THAT THE TRACH HEAD CRACKED ON TWO (2) SIZE 6 CFN, CUFFLESS FENESTRATED TRACHEOSTOMY TUBES. LIMITED INFO REGARDING THE REPORTED EVENTS WAS AVAILABLE. IT IS UNKNOWN HOW LONG THE DEVICES WERE IN USE OR WHAT TYPE OF DEVICE MAINTENANCE WAS PRACTICED. THERE WAS ONE (1) PT INVOLVED WITH NO REPORTED PT COMPROMISE. TWO 6CFN OUTER CANNULAE WERE RETURNED TO THE MFR ON 5/16/97 FOR ANALYSIS AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFLESS FENESTRATED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6CFN M56569000;9499077000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN