BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANDREWS PYNCHON SUCTION TUBE

    MDR report key: 4787079 · Received May 8, 2015

    Report

    Report Number
    4787079
    Event Type
    Death
    Date Received
    May 8, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 8, 2015
    Manufacturer
    AESCULAP, INC.
    Product Code
    JOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIFFICULTY OBTAINING END TIDAL CO2 WHILE ATTEMPTING TO PLACE TRACH. CPR INITIATED, PATIENT REINTUBATED WITH TRACH PLACEMENT, STABILIZED AND VENTILATED WELL. CHEST X-RAY SHOWED PIECE OF SUCTION DEVICE NOTED TO BE MISSING AFTER INTUBATION. PATIENT BECAME HEMODYNAMICALLY UNSTABLE, CPR INITIATED, UNABLE TO VENTILATE THROUGH TRACH TUBE; IT WAS EXCHANGED WITH EXTRA LONG TRACH TUBE FOR BETTER VENTILATION. PATIENT TRANSFERRED TO CARDIAC INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302540 ANDREWS PYNCHON SUCTION TUBE CATHETER AND TIP, SUCTION JOL AESCULAP, INC. MD613 *
    302541 PORTEX TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO AESCULAP, INC. 9MM 505090

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death YES.