BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER

    MDR report key: 1028536 · Received March 27, 2008

    Report

    Report Number
    1028536
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 27, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A CARDINAL PLEURX CATHETER WAS PLACED FOR THE DRAINAGE OF PLEURAL FLUID. ABOUT TWO WEEKS LATER, THE CATHETER WAS REMOVED BECAUSE THERE WAS LEAKING AROUND THE CATHETER SITE AND THE CATHETER HAD BECOME DISLODGED. IT WAS SUBSEQUENTLY DETERMINED THAT THERE HAVE BEEN 10 OTHER PATIENTS THAT HAVE HAD PLEURX CATHETERS PLACED AT OUR FACILITY BETWEEN 11/27/07 AND 2/20/08 THAT HAVE HAD COMPLICATIONS THAT INCLUDE LEAKAGE AROUND THE CATHETER SITE, INFECTION AT THE CATHETER SITE, OR THE CATHETER BECOMING DISLODGED. CLINICIANS INVOLVED HAVE EXPRESSED THAT THE COMPLICATIONS DESCRIBED ABOVE MAY BE RELATED TO CATHETERS NOT ADHERING TO THE SKIN AS THEY WERE DESIGNED TO DO. ALSO, INFORMATION PROVIDED TO US BY THE MANUFACTURER (CARDINAL HEALTH) INDICATES THAT EXCESSIVE AMOUNTS OF GLUE USED DURING THE MANUFACTURING PROCESS ALLOWED THE ADHESIVE TO COME IN CONTACT WITH THE CUFF MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX PLEURAL CATHETER CATHETER, PLEURAL DRAINAGE KDQ CARDINAL HEALTH PLEURX PLEURAL CATHETER L79256

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR