BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3946332 · Received July 10, 2014

    Report

    Report Number
    2936999-2014-00633
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    COVIDIEN.
    Product Code
    JOH
    PMA / PMN Number
    K051416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION WAS PERFORMED. AN ATTEMPT MADE TO INFLATE THE RETURNED UNIT FAILED. THE RETURNED UNIT WAS THEN LEAK TESTED UNDER WATER AND SHOWED AN AIR LEAK FROM THE MAIN BODY OF THE CUFF. FURTHER EXAMINATION USING THE MICROVU SHOWS A SCUFF MARK ON THE CUFF AND A SLIT. THIS TYPE OF DAMAGE IS INDICATIVE OF THE CUFF COMING IN CONTACT WITH A SHARP UTENSIL / OBJECT OR BONY ANATOMICAL FEATURES. THE REPORTED DEFECT WAS CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY COVIDIEN ON (B)(6) 2014. IT WAS DECONTAMINATED, AND FORWARDED TO (B)(4) ON (B)(4)M2014 FOR AN EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, A PATIENT INTUBATED WITH A TRACHEOSTOMY TUBE XLT CUFFED, EXPERIENCED A TRACHEAL FAILURE WHERE THE VENTILATOR LOW VOLUME ALARMED, AND THE PATIENT HAD DIFFICULTY VENTILATING. THE EVENT OCCURRED ON (B)(6) AT 06:00 HRS, WHEN THE TRACHEAL TUBE WAS REPLACED AND THE PATIENT TOLERATED IT WELL. THE CALLER STATED THAT THE TUBE WAS PRE-TESTED, AND IT WAS LUBRICATED WITH A SMALL AMOUNT OF LIDOCAINE GEL. THE CALLER ALSO INFORMED THAT THE PATIENT WAS BEING SEEN BY A PHYSICIAN TO CHECK HIS TRACHEA, AND NO ANOMALIES WERE FOUND. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405016 MALLINCKRODT TRACHEOSTOMY TUBE XLT CUFFED JOH COVIDIEN. 60XLTCP 201401335X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention