BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI LO EVAC

    MDR report key: 1040437 · Received May 7, 2008

    Report

    Report Number
    2936999-2008-00200
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO CONTACT THE HOSPITAL WHERE THE EVENT OCCURRED AND THERE HAS BEEN NO RESPONSE TO DATE. THE TUBE WAS DISCARDED AND THEREFORE, NOT AVAILABLE FOR FAILURE INVESTIGATION. THE LOT NUMBER IS UNK. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. A MANUFACTURING CAPA IS ALREADY IN PLACE TO ADDRESS CUFF LEAKS. THE MANUFACTURER'S DIRECTIONS FOR USE STATES UNDER WARNING/PRECAUTIONS: VARIOUS BONY ANATOMICAL STRUCTURES (E.G., TEETH, TURBINATES) WITHIN THE INTUBATION ROUTES OR ANY INTUBATION TOOLS WITH SHARP SURFACES PRESENT A THREAT TO MAINTAINING CUFF INTEGRITY. CARE MUST BE TAKEN TO AVOID DAMAGING THE THINWALLED CUFFS DURING INSERTION, WHICH WOULD CREATE THE NEED TO SUBJECT THE PT TO THE TRAUMA OF EXTUBATION AND RE-INTUBATION. IF THE CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED.

    Description of Event or Problem · 1

    A COMPANY REP CALLED IN AND REPORTED A PT WITH A 7.5MM HI-LO EVAC ENDOTRACHEAL TUBE HAD A CUFF LEAK. THE TUBE PRODUCED AN AUDIBLE LEAK, AND THE PT WAS REINTUBATED WITH THE SAME SIZE HI-LO EVAC. THE LEAK HAD OCCURRED OVER THE PAST TWO WEEKS AND WAS USED FOR ABOUT A WEEK BEFORE THE EVENT. THE CUFF WAS PRE-TESTED. JELLY WAS USED TO LUBRICATED THE TUBE. THERE WAS NO REPORT OF A DIFFICULT INTUBATION, AND THE TUBE HAD NOT BEEN CUT. THE TUBE POSITION WAS CONFIRMED BY X-RAY, AND WAS 23CM AT THE MOUTH. NO PT INFO WAS AVAILABLE. THE FACILITY DISPOSED OF THE ET TUBE, AND NO LOT NUMBER WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI LO EVAC ENDOTRACHEAL TUBE W/CUFF BTR COVIDIEN, FORMERLY TYCO 7.5MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention