BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3935548 · Received June 23, 2014

    Report

    Report Number
    2936999-2014-00530
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ET REFERENCED IN THIS REPORTED EVENT WAS DISCARDED FOLLOWING EXTUBATION. THERE WAS NO ADD'L INFO PROVIDED. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT REC'D FROM THE USA STATED A KINK WAS LOCATED BETWEEN THE VOCAL CORDS AND THE CUFF OF AN UNSPECIFIED ENDOTRACHEAL TUBE (ET). IT WAS REPORTED, THE PATIENT ARRIVED TO THE INTENSIVE CARE UNIT (ICU) INTUBATED. DURING A F/U, THE RESPIRATORY THERAPIST STATED A FEW DAYS FOLLOWING THE PATIENT'S ARRIVAL THE SUCTION CATHETER COULD NOT BE PASSED THROUGH THE ET CAUSING THE NEED TO EXTUBATE. THE ET WAS REMOVED AND THE PATIENT WAS RE-INTUBATED WITH AN IDENTICAL ET WITHOUT FURTHER INCIDENT. THE RESPIRATORY THERAPIST DID NOT RECALL SPECIFIC DETAILS REGARDING THE EVENT. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364630 MALLINCKRODT UNSPECIFIED ETT BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention