BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM CONTACT® STANDARD EMG REINFORCED ENDOTRACHEAL TUBE

    MDR report key: 4163482 · Received October 10, 2014

    Report

    Report Number
    1045254-2014-00252
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    September 17, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT EVALUATION: DEVICE WAS EVALUATED BY QE. FROM VISUAL EVALUATION, NO OBVIOUS DAMAGE WAS OBSERVED ON THE DEVICE WITH UNAIDED EYE. A LEAK TEST WAS PERFORMED USING A 10 ML SYRINGE TO INFLATE THE CUFF UNDER WATER. UPON INFLATION, NO WATER BUBBLES WERE NOTICED AT THE CUFF ASSEMBLY. THE INFLATION LUMEN TO EMG TUBE BOND AREA WAS PLACED IN BEAKER AND AGAIN NO WATER BUBBLES WERE NOTICED AT THIS LOCATION. THE CUFF APPEARED TO HOLD PRESSURE WHEN OBSERVED FOR SEVERAL MINUTES. METHOD: SIMULATED USE TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS INTUBATED WITH THE TUBE AND THEN IT WAS FOUND THERE WAS A LEAK IN THE BALLOON. THE BALLOON/LEAK WOULD NOT SEAL AND THEY DIDN¿T HAVE GOOD AIRWAY, SO THEY RE-INTUBATED THE PATIENT WITH A NEW TUBE. POST-OP THE PATIENT SAID THAT 5 OF THEIR TEETH WERE CHIPPED DURING THE PROCEDURE. THE FACILITY DOES NOT KNOW IF THE DENTAL DAMAGE OCCURRED DURING THE FIRST OR SECOND INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640517 NIM CONTACT® STANDARD EMG REINFORCED ENDOTRACHEAL TUBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229306 0208257781

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention