BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 875854 · Received September 13, 2006

    Report

    Report Number
    1717671-2006-00003
    Event Type
    Malfunction
    Date Received
    September 13, 2006
    Date of Event
    August 16, 2006
    Report Date
    September 13, 2006
    Manufacturer
    DBI
    Product Code
    KPM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRODUCER INVOLVED IN THE INCIDENT IS NOT MANUFACTURED BY DBI. IT IS A PURCHASED COMPONENT THAT IS USED WITHIN THE PLEURX PLEURAL CATHETER KIT. THE INTRODUCER USED DURING THE PROCEDURE, ALONG WITH THE USED DBI SHEATH HAVE BEEN RETURNED TO THE INTRODUCER MFR FOR EVAL.

    Description of Event or Problem · 1

    DURING THE INITIAL PLACEMENT OF THE PLEURAL CATHETER, THE PHYSICIAN ALLEGED THE CATHETER COULD NOT BE PLACED THROUGH THE 16FR INTRODUCER PROVIDED WITH THE KIT. THE PHYSICIAN, A FIRST TIME USER OF THE PRODUCT, MADE SEVERAL ATTEMPTS TO PLACE THE PRODUCT. THE SHEATH WAS REMOVED AND A PNEUMOTHORAX DEVELOPED. A SECOND INTRODUCER WAS OBTAINED, AND THE CATHETER WAS SUCCESSFULLY PLACED. THE PT WAS OBSERVED OVERNIGHT IN THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX PLEURAL CATHETER KIT PLEURAL CATHETER KIT KPM DBI 50-7000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization