BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 212310 · Received March 1, 1999

    Report

    Report Number
    212310
    Event Type
    Injury
    Date Received
    March 1, 1999
    Date of Event
    January 22, 1999
    Report Date
    February 4, 1999
    Manufacturer
    MALLINCKRODT MED. TPI
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CANNULA & INNER CANNULA BROKE AWAY FROM BASE PLATE THAT WAS SUTURED TO SKIN, TRACH TUBE DISLODGED FROM TRACHEA, CUFF INTACT. TAB OIN BASE PLATE THAT HOLDS CANNULA IN PLACE MISSING. MD ANCHORED CANNULA IN PLACE WITH SUTURE UNTIL REPLACED IN 2-3-99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SHILEY DISPOSABLE TRACH TUBE BTO MALLINCKRODT MED. TPI UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R