BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3980982 · Received July 24, 2014

    Report

    Report Number
    2936999-2014-00684
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K051416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USER FACILITY STATED A TRACHEOSTOMY TUBE WAS RECEIVED IN AN UNUSABLE CONDITION. THE USER FACILITY REPORTED THAT THE TUBE WAS DELIVERED STRAIGHT INSTEAD OF CURVED. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE TO THE MANUFACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435114 MALLINCKRODT TRACHEOSTOMY TUBES JOH COVIDIEN 201401194X

    Patients

    Seq Age Sex Outcome Treatment
    1