BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEUR-EVAC

    MDR report key: 1052668 · Received May 20, 2008

    Report

    Report Number
    1052668
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 20, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF ENTERED PATIENT'S ROOM TO FIND CHEST TUBE Y CONNECTION DISCONNECTED FROM THE PLEURO-VAC. STAFF NOTED THAT ALTHOUGH A ZIP-STRIP WAS IN PLACE TO SECURE THE TUBING TO THE PLEURO-VAC, IT WAS LOOSE AND EASILY DETACHED FROM THE MAIN UNIT. THE CHEST TUBE WAS CLAMPED AND ULTIMATELY ATTACHED TO A NEW SUCTION UNIT. MD AND APN WERE NOTIFIED AND CAME TO THE BEDSIDE. NO PATIENT HARM. VITAL SIGNS REMAINED STABLE AND ASSESSMENT WAS UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUR-EVAC CHEST DRAINAGE UNIT KDQ TELEFLEX MEDICAL * 02L0700548

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR OTHER| OTHER