BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLING/WECK/TELEFLEX

    MDR report key: 1344423 · Received December 12, 2008

    Report

    Report Number
    1344423
    Event Type
    Death
    Date Received
    December 12, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SET OF DILATORS WAS IMMEDIATELY PULLED FROM SERVICE.

    Description of Event or Problem · 1

    THIS PT 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 PT'S SAO2 AND HEART RATE IMMEDIATELY DROPPED; CPR WAS INITIATED ; ET TUBE WAS INSERTED. AFTER THE PT WAS SUCCESSFULLY RESUSCITATED, THE ET TUBE WAS REMOVED AND DILATATION CONTINUED. AFTER THE PROCEDURE THE PT WAS RETURNED TO THE ICU WHERE HE REMAINED UNRESPONSIVE TO ORAL OR PAIN STIMULI.

    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