BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3970342 · Received July 11, 2014

    Report

    Report Number
    2936999-2014-00642
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 13, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE HAS BEEN DISCARDED, AND ANOTHER PRODUCT IN THE INVENTORY WAS RETURNED INSTEAD, FOR CREDIT PROPOSES. THEREFORE, NO EVALUATION WILL PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, FOUR DAYS AFTER INTUBATION OF A LOW PRESSURE CUFFED TRACHEOSTOMY TUBE WITH EVACUATION LINE, THE CUFF WAS UNABLE TO BE DEFLATED. THE TUBE WAS REMOVED BY CUTTING THE INFLATION LINE, AND A NEW REPLACEMENT DEVICE WAS RECANNULATED. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407021 SHILEY TRACHEOSTOMY TUBE JOH COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention