BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 4041070 · Received August 12, 2014

    Report

    Report Number
    2936999-2014-00757
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 4, 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 REFERENCED TRACHEOSTOMY TUBE WAS RECEIVED FOR EVALUATION. AN INFLATION/ DEFLATION TEST WAS PERFORMED USING 25CC OF AIR; USING A SYRINGE. THE CUFF WAS OBSERVED TO RESIST INFLATION AND DEFLATION OF THE CUFF WAS "HARD". VISUAL EXAMINATION OF THE CUFF SHOWED THE INFLATION LINE TO BE IMPROPERLY ASSEMBLED. THE INFLATION LINE WAS FOUND TO BE IN THE OPPOSITE POSITION AS IT WAS INTENDED. THE INFLATION LINE WAS ALSO FOUND TO HAVE AN IRREGULAR CUT CAUSING OCCLUSION. ALL MANUFACTURING CONTROLS WERE FOUND ACCEPTABLE AND EFFECTIVE TO DETECT THE REPORTED FAILURE MODE. AN INFLATION TEST IS PERFORMED FOR ALL PRODUCTS. THE OPERATOR INSPECTS ALL PRODUCTS FOR NO LEAKS AND SEGREGATES THE DEFECTIVE PARTS. ALL PRODUCTS HAVE A RESTING TIME OF 2 HOURS. A DEFLATION TEST IS PERFORMED FOR ALL PRODUCTS. THE OPERATOR INSPECTS FOR NO LEAKS AND NO RESTRICTION AND SEGREGATES THE DEFECTIVE PARTS.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT STATING, DURING PRIOR TO USE TESTING, THE NURSE FELT RESISTANCE WHILE ATTEMPTING TO INFLATE THE TRACHEAL TUBE'S CUFF. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479191 SHILEY TRACHEOSTOMY TUBE BTR COVIDIEN 13J0924JZX

    Patients

    Seq Age Sex Outcome Treatment
    1