BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3890834 · Received June 11, 2014

    Report

    Report Number
    2936999-2014-00512
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 13, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTO
    PMA / PMN Number
    K810106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE IS EXPECTED TO BE RETURNED. WITHOUT THE ACTUAL COMPLAINT SAMPLE A FULL INVESTIGATION CANNOT BE COMPLETED, THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS SPECIFIC EVENT, HOWEVER, MANUFACTURING CONTROLS ARE IN PLACE TO DETECT RELATED ISSUES AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. INFORMATION OF THIS NATURE IS INCLUDED IN OUR DATABASE AND MONITORED THROUGH TRENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: INABILITY TO MAINTAIN CUFF PRESSURE. INFORMATION PROVIDED SUGGEST THAT A REPLACEMENT TUBE WAS REQUIRED. CUSTOMER CONFIRMED THAT NO FAULT WAS IDENTIFIED DURING PRETESTING EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345350 SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE BTO COVIDIEN 13F0176JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention