BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE

    MDR report key: 221332 · Received April 29, 1999

    Report

    Report Number
    2029387-1999-00017
    Event Type
    Injury
    Date Received
    April 29, 1999
    Date of Event
    November 27, 1998
    Report Date
    January 27, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Report Source
    Manufacturer report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA RECEIPT OF FACILITY MEDWATCH REPORT THAT A PT INTUBATED WITH A SIZE 8 SCT, SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE, REQUIRED MEDICAL INTERVENTION AND HOSPITALIZATION WHEN THE DEVICE REPORTEDLY "KINKED," OBSTRUCTING THE PT'S AIRWAY. THE 8 SCT DEVICE WAS REMOVED AND PT WAS INTUBATED WITH AN ENDOTRACHEAL TUBE AND HOSPITALIZED. LIMITED INFO WAS PROVIDED TO THE MFR REGARDING THE REPORTED EVENT, PT AND DEVICE. IT IS UNK HOW LONG THE DISPOSABLE DEVICE HAD BEEN IN USE AND WHAT TYPE OF TRACHEOSTOMY CARE AND MAINTENANCE WAS PERFORMED. THE INVOLVED 8 SCT DEVICE IS REPORTEDLY AVAILABLE TO BE RETURNED TO THE MFR FOR IDENTIFICATION, ANALYSIS AND INVESTIGATION. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RECEIVED BY THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE Implant * BTO MALLINCKRODT MEDICAL, INC. 8 SCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1