BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3142930 · Received May 29, 2013

    Report

    Report Number
    2936999-2013-00401
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: "THAT THE TUBE HAD A LEAK IN THE PILOT BALLOON THAT PREVENTED THE CUFF FROM STAYING INFLATED. THE TRACH WAS IN USE FOR APPROXIMATELY 3 DAYS, AND HAD TO BE REPLACED DUE TO THE LEAK. THIS WAS OUTSIDE OF THE NORMAL TRACH REPLACEMENT SCHEDULE. THE PT RECEIVED ANOTHER 8DCT AND IS DOING OK. THE TRACH WAS INSTALLED (B)(6) 2013. THE TRACH WAS PRE-TESTED AND INFLATED TO 8-9 ML AIR USING A STETHOSCOPE FOR ASSISTANCE. THE TRACH WAS NOT CLEANED DURING THIS TIME. THE PT DOES NOT HAVE ANY ANATOMICAL ANOMALIES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234018 SHILEY DISPSOABLE CANNULA LOW PRESSURE CUF JOH COVIDIEN 120200379X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention