BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE

    MDR report key: 218636 · Received April 5, 1999

    Report

    Report Number
    2029387-1998-00089
    Event Type
    Death
    Date Received
    April 5, 1999
    Date of Event
    July 11, 1998
    Report Date
    August 14, 1998
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFLATION COULD NOT BE MAINTAINED ON TWO SIZE 6 SCT, SINGLE CANNULA CUFFED TRACHEOSTOMY TUBES. THE INFO REC'D INDICATES THAT ON 7/11/98 A PT ARRIVED IN THE ER IN FULL RESPIRATORY DISTRESS. THE ATTENDING ER PHYSICIAN PERFORMED AN EMERGENCY TRACHEOTOMY PROCEDURE AND AFTER PLACING THE FIRST SIZE 6 SCT WAS UNABEL TO INFLATE THE DEVICE CUFF. THE DEVICE WAS REMOVED AND A SECOND SIZE 6 SCT DEVICE WAS PLACED WITH THE SAME RESULTS. THE SECOND 6 SCT DEVICE WAS REMOVED AND PT WAS INTUBATED WITH A ENDO TRACHEAL TUBE AND PLACED ON MECHANICAL VENTILATION. THE TWO SIZE 6 SCT DEVICES WERE EXAMINED BY THE ATTENDING MEDICAL STAFF WHERE THE 6 SCT DEVICES WERE DISCARDED AND AS SUCH ARE NOT AVAILABLE TO BE RETURNED TO THE MFR FOR IDENTIFICATION, ANALYSIS AND INVESTIGATION. IT HAS SINCE BEEN REPORTED THAT ON 07/16/98 THE PT EXPIRED. LIMITED INFO HAS BEEN PROVIDED TO THE MFR REGARDING THE PT, INCLUDING MEDICAL CONDITION(S), SUBSEQUENT TREATMENTS AND DIAGNOSIS AND OR CAUSE OF DEATH. IT WAS NOT REPORTED THAT THE INCIDENT INVOLVING THE SIZE 6 SCT DEVICES CAUSED OR CONTRIBUTED TO THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6 SCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| R