BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE UNCUFFED ENDOTRACHEAL TUBE

    MDR report key: 1632588 · Received March 4, 2010

    Report

    Report Number
    2183502-2010-00053
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    January 27, 2010
    Report Date
    February 25, 2010
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTR
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    9610530-09/08/09-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 F/U 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 1676503

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK