BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE NIM EMG 6MM RE

    MDR report key: 2141009 · Received June 27, 2011

    Report

    Report Number
    1045254-2011-00046
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    April 25, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MEDTONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1045254-2011-00046 WAS SUBMITTED ON (B)(4), 2011. ORIGINALLY LABELED AS HOSPITALIZATION -INITIAL OR PROLONGED ON THE ORIGINAL MDR. THIS REPORT IS IDENTIFIED AS A PRODUCT PROBLEM AND NO PATIENT INJURY WAS REPORTED. DID NOT ORIGINALLY INDICATE THE ITEM WAS NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A MEDWATCH WAS RECEIVED FROM THE CUSTOMER WHICH DID NOT CONTAIN A UF / IMPORTER REPORT NUMBER FROM THE CUSTOMER. SINCE RECEIVING IT, SEVERAL DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER REGARDING FURTHER PRODUCT INFORMATION, AND DETERMINE IF THE PRODUCT IS TO BE RETURNED FOR ANALYSIS. THIS PRODUCT IS USED FOR TREATMENT AND NOT FOR DIAGNOSIS.

    Description of Event or Problem · 1

    DESCRIPTION OF THE EVENT: DURING AN ANTERIOR CERVICAL SURGICAL PROCEDURE WITH A EMG ENDOTRACHEAL TUBE, THE ANESTHESIOLOGISTS NOTICED A WIRE HANGING OUT OF THE PATIENT'S MOUTH. THE EMG TUBE WAS REMOVED AND THE ENTIRE WIRE REMAINED INTACT. THE PATIENT WAS THEN INTUBATED WITH A REGULAR ET TUBE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT. THE REVIEW OF THE PRODUCT DOCUMENT HISTORY REPORT DID NOT INDICATE ANY ABNORMALITIES IN THE MANUFACTURING OF THIS LOT. A REVIEW OF THE COMPLAINT HISTORY INDICATES THERE HAVE BEEN NO REPORTS OF THIS NATURE FOR THIS LOT, AND NO QUALITY NON-CONFORMANCE REPORTS ISSUED DURING THE MANUFACTURING PROCESS OF THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE NIM EMG 6MM RE STIMULATOR, NERVE ETN MEDTONIC XOMED INC. 8229306 72334400

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization