BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO PRO TRACHEAL TUBE

    MDR report key: 91917 · Received May 15, 1997

    Report

    Report Number
    91917
    Event Type
    Malfunction
    Date Received
    May 15, 1997
    Date of Event
    May 6, 1997
    Report Date
    May 13, 1997
    Manufacturer
    MALLINCKRODT CRITICAL CARE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER AN INSERTION OF A NASO-GASTRIC TUBE. A CUFF TEAR WAS NOTED. PT WAS REINTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LO PRO TRACHEAL TUBE CUFFED ENDO-TRACHEAL TUBE BTR MALLINCKRODT CRITICAL CARE UNK MJ 07700

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other