BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 4260188 · Received November 18, 2014

    Report

    Report Number
    2936999-2014-00982
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 19, 2014
    Report Date
    October 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K955680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRACHEOSTOMY TUBE IS STILL BEING USED IN THE PATIENT AND IS SCHEDULED TO BE REPLACED ON (B)(6) 2014. COVIDIEN HAS REQUESTED RETURN OF THE DEVICE ONCE IT IS REMOVED. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION FROM A CUSTOMER STATING THAT THE CUFF ON A SHILEY TRACHEOSTOMY TUBE PARTIALLY REINFLATED AFTER IT IS DEFLATED. THE CUSTOMER THINKS THERE IS A FAULT WITH THE PILOT BALLOON. THE TRACHEOSTOMY TUBE WAS IN USE ON A PATIENT AT THE TIME OF THE MALFUNCTION. THE TUBE REMAINED IN PLACE AND WAS NOT EXCHANGED AS A RESULT OF THE REPORTED MALFUNCTION. THERE WAS NO PATIENT INJURY OR HARM AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746752 SHILEY TRACHEOSTOMY TUBE JOH COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1