BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTRACH ETT

    MDR report key: 808717 · Received January 16, 2007

    Report

    Report Number
    808717
    Event Type
    Malfunction
    Date Received
    January 16, 2007
    Date of Event
    January 1, 2007
    Report Date
    January 16, 2007
    Manufacturer
    LMA NORTH AMERICA, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INITIALLY INTUBATED AFTER A SPLENECTOMY. INTUBATION WAS DIFFICULT AND CAUSED A TONGUE LACERATION NOT DUE TO A PRODUCT DEFECT. THE NEXT DAY THE ET TUBE WAS FOUND CURLED UP IN HER MOUTH WHICH REQUIRED REINTUBATION. DURING THE REPEAT INTUBATION, THE BALLOON ON THE ET TUBE WOULD NOT INFLATE, WHICH REQUIRED ANOTHER INTUBATION. THE PATIENT WAS NOT COMPROMISED DURING THESE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTRACH ETT TUBE, ENDOTRACHEAL BTR LMA NORTH AMERICA, INC. 6.5 MM ORAL 00412141

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR