BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIT. PLEURX PLEURAL CATHETER

    MDR report key: 996404 · Received February 11, 2008

    Report

    Report Number
    1423507-2008-00014
    Event Type
    Other
    Date Received
    February 11, 2008
    Date of Event
    January 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO LOT NUMBER OR PRODUCT SAMPLE WAS PROVIDED FOR EVALUATION, THE INVESTIGATION RESULTS WERE INCONCLUSIVE. A REVIEW OF THE COMPLAINT TRACKING SYSTEM DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THIS FAILURE MODE. CONSEQUENTLY, NO ROOT CAUSE WAS IDENTIFIED FOR THIS FAILURE. PLEASE NOTE THAT THE INSTRUCTIONS FOR USE STATE "WARNINGS: DO NOT PUT ANYTHING EXCEPT THE DRAINAGE LINE'S ACCESS TIP INTO THE PLEURX PLEURAL CATHETER VALVE. DAMAGE TO THE VALVE COULD OCCUR IF ACCESS IS ATTEMPTED WITH ANOTHER DEVICE. A DAMAGED VALVE MAY NOT FUNCTION PROPERLY AND THEREBY MAY PERMIT AIR TO LEAK INTO THE PATIENT'S CHEST OR PLEURAL FLUID TO LEAK OUT FROM THE CATHETER." THIS INCIDENT INFORMATION WILL BE ADDED TO THE QUALITY COMPLAINT TRACKING SYSTEM FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    LEAKING THROUGH VALVE OF CATHETER. CATHETER HAD TO BE REPLACED, REQUIRING SURGERY. IT WAS LATER DISCOVERED THAT SOME OF THE NURSES ADMITTED "THEY STUCK SOMETHING METAL IN THE VALVE" AND THAT'S WHY IT LEAKED. THE NEW CATHETER IS FINE, NOT LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT. PLEURX PLEURAL CATHETER PLEURAL CATHETER GCB CARDINAL HEALTH 50-7000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention