BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLING /WECK/ TELEFLEX

    MDR report key: 1352681 · Received December 9, 2008

    Report

    Report Number
    1352681
    Event Type
    Death
    Date Received
    December 9, 2008
    Date of Event
    November 25, 2008
    Report Date
    December 9, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KCG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS BROUGHT TO THE OR FOR RIGID BRONCHOSCOPY AND TRACHEAL DILATATION. DURING THE PROCEDURE, THE TIP OF THE DILATOR (#22 PILLING) AND THE BODY OF THE DILATOR BECAME SEPARATED. THE TIP LODGED IN THE RIGHT MAIN STEM BRONCHUS. THE PATIENT'S SAO2 AND HEART RATE IMMEDIATELY DROPPED; CPR WAS INITIATED, ET TUBE WAS INSERTED. AFTER THE PATIENT WAS SUCCESSFULLY RESUSCITATED, THE ET TUBE WAS REMOVED AND DILATATION CONTINUED. AFTER THE PROCEDURE, THE PATIENT WAS RETURNED TO THE ICU WHERE HE REMAINED UNRESPONSIVE TO ORAL OR PAIN STIMULI. DEVICE EVALUATED BY MFR: NOT RETURNED TO MFR. THE SET OF DILATORS WAS IMMEDIATELY PULLED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING /WECK/ TELEFLEX BRONCHIAL DILATOR KCG TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death