BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT 7.O ET

    MDR report key: 726991 · Received June 9, 2006

    Report

    Report Number
    726991
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Date of Event
    March 14, 2006
    Report Date
    June 9, 2006
    Manufacturer
    MALLINCKRODT
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS INTUBATED BY ANESTHESIA TEAM. FOLLOW-UP SHOWED MINIMAL TIDAL VOLUME LOSS. THE NEXT DAY THE PHYSICIAN REQUESTED REINTUBATION FOR POSSIBLE LEAKAGE OF CUFF. ANESTHESIA REINTUBATED AND FOUND CUFF RUPTURED. DUE TO TIMING FELT TO BE RELATED TO INITIAL INTUBATION. PATIENT SUFFERED NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT 7.O ET TUBE, ENDOTRACHEAL BTR MALLINCKRODT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR