BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE

    MDR report key: 2930699 · Received January 28, 2013

    Report

    Report Number
    1045254-2013-00045
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 28, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). ANALYSIS CONFIRMED A VISIBLE PIN HOLE SIZE TEAR PREVENTING THE CUFF FROM STAYING INFLATED WITH AIR. TWO OF THE FOUR ELECTRODE WIRES WERE SEVERELY BENT WITH ONE WIRE TORN THROUGH THE LUMEN NEAR ITS DISTAL TIP, MOST LIKELY DUE TO MISHANDLING AND/OR MANEUVERING OF THE PRODUCT DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIP OF A WIRE ELECTRODE PERFORATED THE BALLOON/CUFF OF AN ENDOTRACHEAL TUBE PREOPERATIVELY ON (B)(6) 2012. THE NURSE DISCOVERED THE ISSUE PRIOR TO INTUBATING THE PATIENT AND THEREFORE WAS NOT USED ON THE PATIENT TO CAUSE IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37315 ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8229307 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1