BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE

    MDR report key: 251231 · Received November 2, 1999

    Report

    Report Number
    2029387-1999-00054
    Event Type
    Malfunction
    Date Received
    November 2, 1999
    Report Date
    October 28, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY INTERNATIONAL MALLINCKRODT FACILITY (JAPAN) THAT INFLATION COULD NOT BE MAINTAINED ON ONE (1), SIZE 5 SCT, SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE. THE DEVICE HAD REPORTEDLY BEEN IN USE APPROXIMATELY TWO (2) TO THREE (3) HOURS WHEN THE PROBLEM WAS DETECTED. THE DEVICE WAS REPORTEDLY TESTED PRIOR TO INTUBATION. LIMITED INFORMATION IS AVAILABLE REGARDING THE PT AND THE REPORTED EVENT. THERE WAS ONE (1) PT INVOLVED WITH NO REPORTED PT INJURY. THE SIZE 5 SCT DEVICE WAS RETURNED ON 03/02/1999 TO THE MANUFACTURER FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 5 SCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN