BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEUR-EVAC

    MDR report key: 1070775 · Received June 26, 2008

    Report

    Report Number
    1070775
    Event Type
    Malfunction
    Date Received
    June 26, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 26, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING DEVICE TESTING BEFORE USING ON PATIENT, WATER WAS ADDED TO THE WATER SEAL CHAMBER TO TEST FOR LEAKS. WATER LEAKED INTO THE COLLECTION CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUR-EVAC CHEST DRAINAGE SYSTEM KDQ TELEFLEX MEDICAL * 02B0800514

    Patients

    Seq Age Sex Outcome Treatment
    1 *