BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 211587 · Received February 18, 1999

    Report

    Report Number
    211587
    Event Type
    Malfunction
    Date Received
    February 18, 1999
    Date of Event
    September 4, 1998
    Report Date
    September 14, 1998
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS THE TRACHEOSTOMY TUBE WAS INSERTED. PRESSURE WAS APPLIED AND THE SWIVEL NECK FLANGE BROKE. A NEW TUBE WAS INSERTED WITH NO PROBLEM. THE NEW TUBE WAS IDENTICAL TO THE 1ST TUBE. NO INJURY TO PATIENT AND NO OTHER PROBLEMS WITH THE NEW TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFLESS TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL TPI, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other