BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2969203 · Received February 11, 2013

    Report

    Report Number
    2936999-2013-00082
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTH
    Product Code
    BTQ
    PMA / PMN Number
    K760125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP EFFORTS MADE ON (B)(4) 2013 WITH STAFF QUALITY SPECIALIST CONFIRMED AWARENESS THAT THEY ARE USING THE PRODUCT IN ON OFF LABEL USE. NO SAMPLE WILL BE MADE AVAILABLE FOR FURTHER ANALYSIS OF THIS REPORT.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED THE FOLLOWING CUSTOMER REPORT VIA EMAIL: MEDWATCH UF / IMPORTER REPORT (B)(4). THE DETAILS OF THE REPORT STATE THE PT EXPERIENCED A RESPIRATORY ARREST FOLLOWING SECOND NIGHT POST-OP OR PROCEDURE. REPORT ALSO STATES THE PT WAS HEMODYNAMICALLY UNSTABLE THAT A BEDSIDE BRONCHOSCOPY COULD NOT BE PERFORMED UNTIL FIVE DAYS POST RESPIRATORY ARREST. AT THAT TIME, A NASAL TRUMPET WAS DISCOVERED WITHIN THE RIGHT BRONCHUS OF THE PT. THE NASAL TRUMPET WAS USED IN THE OPERATING ROOM AND HAD BEEN MODIFIED WITH A SLIT DOWN THE LENGTH OF THE TRUMPET. THE CUSTOMER BELIEVES THE SLIT MODIFICATION MAY HAVE CONTRIBUTED TO THIS RETAINED NASAL TRUMPET AND THAT IT WAS HUMAN ERROR THAT THE ANESTHESIOLOGIST DID NOT REMEMBER TO REMOVE THE NASAL TRUMPET. NEW INFO PROVIDED CONFIRMS THAT THE NASAL TRUMPET HAS SINCE BEEN REMOVED AND THE PT HAS RECOVERED WELL AND DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60188 MALLINCKRODT NASOPHARYNGEAL AIRWAY BTQ COVIDIEN, FORMERLY TYCOHEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention