BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE UNCUFFED ENDOTRACHEAL TUBE

    MDR report key: 2030356 · Received March 21, 2011

    Report

    Report Number
    2183502-2011-00085
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    March 14, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    THE USER ENCOUNTERED DIFFICULTY INSERTING A SUCTION TUBE THROUGH THE ENDOTRACHEAL TUBE WHILE IN SITU. NO LASTING INCIDENT-RELATED MEDICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX BLUE LINE UNCUFFED ENDOTRACHEAL TUBE BTR - ENDOTRACHEAL TUBE BTR SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK