BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3130143 · Received May 21, 2013

    Report

    Report Number
    2936999-2013-00381
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 23, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER STATES: AT EXTUBATION FROM PT AT HOSPITAL, THE CUFF WOULD NOT BE DEFLATED. A DOCTOR HAD A GREAT DIFFICULTY TO REMOVING IT FROM PT. CUSTOMER CONFIRMED THE ISSUE WAS FOUND DURING EXTUBATION EFFORTS AND DID NOT NECESSITATE ANY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225151 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUB BTR COVIDIEN 12J0729JZX

    Patients

    Seq Age Sex Outcome Treatment
    1