BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEURX PLEURAL CATH, MINI

    MDR report key: 1647067 · Received March 18, 2010

    Report

    Report Number
    1625685-2010-00006
    Event Type
    Other
    Date Received
    March 18, 2010
    Date of Event
    January 18, 2010
    Report Date
    March 18, 2010
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBER: L9L246. ADDITIONAL MANUFACTURE DATE: 09/2009. A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVAL. A REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURE MODES. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE QUALITY PLAN FOR THE MANUFACTURE OF THE CATHETER ASSEMBLY INCLUDED SPECIFIC INSTRUCTIONS AND GUIDANCES FOR THE ASSEMBLY OF THE CUFF ONTO THE CATHETER TUBE. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THIS FAILURE MODE. ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS FAILURE MODE IN AN EFFORT TO HEIGHTEN AWARENESS AND MINIMIZE ANY IMPACT FROM THE MANUFACTURING PROCESSES.

    Description of Event or Problem · 1

    CATHETER PLACED AND LATER FELL OUT OF PATIENT. THE TISSUE NEVER IN-GREW AROUND THE CUFF. LOT NUMBER WAS POSSIBLY L9K250 OR L9L246 BASED ON WHAT CUSTOMER SAYS WAS SHIPPED TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX PLEURAL CATH, MINI PLEURAL CATHETER DWM CAREFUSION 50-7050 MAYBE L9K250

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention