BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX IVORY NORTH FACING POLAR PREFORMED ENDOTRACHEAL TUBE

    MDR report key: 8814033 · Received July 22, 2019

    Report

    Report Number
    3012307300-2019-02848
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Date of Event
    June 21, 2019
    Report Date
    September 5, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTR
    UDI-DI
    15019315020353
    PMA / PMN Number
    K931735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE (1) USED SAMPLE WAS RETURNED FOR EVALUATION P/N 100/133/070, UNKNOWN LOT NUMBER; THE SAMPLE WAS RECEIVED IN USED CONDITION. DURING VISUAL INSPECTION, NO DISCREPANCIES WERE FOUND. DURING FUNCTIONAL TESTING A LEAK WAS OBSERVED COMING OUT FROM A TEAR IN THE CUFF. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. THE CUSTOMER CONFIRMED IN A PRE-USE CHECK THAT THE CUFF WORKS PROPERLY. IT IS THE MOST PROBABLE ROOT CAUSE THAT THE CUFF TEAR OCCURED DURING INTUBATION PROCEDURE DUE TO CONTACT WITH SHARP EDGE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT AFTER INTUBATING A SMITHS MEDICAL PORTEX IVORY NORTH FACING POLAR PREFORMED ENDOTRACHEAL TUBE INTO A PATIENT, AIR LEAKED FROM THE DEVICE CUFF. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608313 PORTEX IVORY NORTH FACING POLAR PREFORMED ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL ASD, INC. 100/133/070 15019315020353

    Patients

    Seq Age Sex Outcome Treatment
    1