BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRA DRAINAGE SYSTEM

    MDR report key: 1698634 · Received May 21, 2010

    Report

    Report Number
    MW5016062
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 21, 2010
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DRAINAGE CATHETER PLACED (B) (6) 2010. PT USING DEVICE AT HOME, NO SIGNIFICANT DRAINAGE WHEN USED. FLUID BEGAN LEAKING FROM AROUND INSERTION SITE. DEVICE REMOVED ON (B) (6) 2010. PLASTIC STIFFENER FOUND INSIDE CATHETER. THE STIFFENER WAS REMOVED AT TIME OF INSERTION. UNCERTAIN IF IT BROKE PRIOR TO BEING REMOVED. IT DID NOT APPEAR TO BREAK DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRA DRAINAGE SYSTEM NONE DWM BARD ACCESS SYSTEMS 4491208 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other NEW DEVICE TO BE IMPLANTED