BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 4140847 · Received October 3, 2014

    Report

    Report Number
    2936999-2014-00874
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 11, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ENDOTRACHEAL TUBE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EVALUATION. AN INFLATION/DEFLATION TEST WAS PERFORMED USING A SYRINGE. 25CC'S OF AIR WERE APPLIED TO THE CUFF. THE CUFF WAS OBSERVED TO HAVE A FAULTY INFLATION LINE WHICH MADE INFLATION/DEFLATION OF THE DEVICE DIFFICULT. THE REPORTED FAILURE MODE WAS CONFIRMED IN THE RECEIVED SAMPLE. ALL MANUFACTURING CONTROLS WERE FOUND ACCEPTABLE AND EFFECTIVE TO DETECT THE REPORTED FAILURE MODE. AN INFLATION TEST IS PERFORMED FOR ALL TAPERGUARD PRODUCTS. THE OPERATOR INSPECTS ALL PRODUCTS FOR LEAKS AND SEGREGATES THE DEFECTIVE PARTS. ALL TAPERGUARD PRODUCTS HAVE A RESTING TIME OF TWO HOURS. A DEFLATION TEST IS PERFORMED FOR ALL TAPERGUARD PRODUCTS. THE OPERATOR INSPECTS FOR LEAKS AND SEGREGATES THE DEFECTIVE PARTS. ONCE EACH PART HAS BEEN VISUALLY INSPECTED, OPERATORS ARE INSTRUCTED TO TO DEFLATE THE CUFFS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING A TRACHEAL TUBE'S CUFF DID NOT INFLATE PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620306 SHILEY TRACHEOSTOMY TUBE BTR COVIDIEN 18875 13H0088JZX

    Patients

    Seq Age Sex Outcome Treatment
    1