BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE

    MDR report key: 3182275 · Received June 21, 2013

    Report

    Report Number
    1045254-2013-00429
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4): THE DEVICE WAS RETURNED FOR EVALUATION. THE PRODUCT ANALYSIS FOUND THE TUBING AND ELECTRODE WIRES ARE BENT; THE BLUE ELECTRODE WIRES ARE OUT OF THE LUMEN UNDER THE CUFF AND 1 HAD PUNCTURED THE CUFF. THE INSTRUCTIONS FOR USE [68E4127 REVISION B] INDICATE: ¿DO NOT ATTEMPT TO USE AN EMG TUBE WITHOUT FIRST PERFORMING A CUFF INFLATION TEST¿ THIS WOULD HAVE DETECTED A PUNCTURED OF THE CUFF PRIOR TO USE. THE PRODUCT EVALUATION FINDINGS ARE INDICATIVE OF DAMAGE TO THE TUBE/CUFF/ELECTRODE WIRES AS A RESULT OF DEVICE MISHANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ¿THERE WAS A PROBLEM WITH THE TUBE AND THE CUFF KEPT DEFLATING. THROAT PACKS WERE USED AND THE TUBE WAS REPLACED AT A SAFE AND APPROPRIATE TIME DURING THE PROCEDURE.¿ THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282229 ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229307 0206398997

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention