BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERGUARD ORAL/NASAL TRACHEAL TUBES

    MDR report key: 3962618 · Received June 18, 2014

    Report

    Report Number
    2936999-2014-00527
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE OF A TAPERGUARD ENDOTRACHEAL TUBE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED, AND IT WAS OBSERVED THAT ALL THE COMPONENTS WERE ASSEMBLED PROPERLY AT THE TUBE, ACCORDING TO DRAWING SPECIFICATIONS. AN INFLATION / DEFLATION TEST WAS PERFORMED, USING A SYRINGE 25CC OF AIR APPLIED TO THE CUFF, AND IT WAS CONFIRMED AN INFLATION SYSTEM FUNCTIONING PROPERLY. THE CUFF HELD THE AIR, AND IT WAS LEFT INFLATED FOR 2 HOURS, ACCORDING TO PROCESS INSTRUCTIONS. ADDITIONALLY, THE SAMPLE WAS SUBMERGED INTO A CONTAINER FILLED WITH WATER, AND NO LEAKS WERE NOTED. THE REPORTED FAILURE MODE WAS NOT CONFIRMED ON THE RETURNED SAMPLE. ALL MANUFACTURING CONTROLS WERE FOUND ACCEPTABLE AND EFFECTIVE TO DETECT THE REPORTED FAILURE MODE. AN INFLATION TEST IS PERFORMED FOR ALL TAPERGUARD PRODUCTS PRIOR TO RELEASE. THE OPERATOR INSPECTS ALL PRODUCTS FOR NO LEAKS AND SEGREGATES THE DEFECTIVE PARTS. ONCE THE PART IS INSPECTED VISUALLY THEN THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE GUIDELINES TO DEFLATE THE CUFF. COVIDIEN REFERENCE # RX201405-1962.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER VISUALLY CHECKED THE CUFF, AND IMMERSED IT IN THE WATER, BUT NO HOLES WERE CONFIRMED. THE UNIT IS EXPECTED TO BE RETURNED AND EVALUATED, BUT IS NOT YET RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, DURING PT USE AND AFTER 5 SUTURE OF INTUBATION, A TAPERGUARD ORAL/NASAL TRACHEAL TUBE LEAKED, AND THE SPO2 LOWERED. A PRESSURE GAUGE WAS USED TO MANAGE THE PRESSURE, BUT THE LEAK DID NOT STOP. ANOTHER TAPERGUARD TUBE WAS RE-INTUBATED. IT IS UNK IF LUBRICATION WAS USED. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356848 TAPERGUARD ORAL/NASAL TRACHEAL TUBES BTR COVIDIEN 18880 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention