BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT, PLEURX PLEURAL CATHETER

    MDR report key: 1033998 · Received April 25, 2008

    Report

    Report Number
    1423507-2008-00038
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 25, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS REC'D FOR EVALUATION AND WAS VISUALLY EVALUATED UNDER MAGNIFICATION BY THE QUALITY AND ENGINEERING PERSONNEL AT THE MANUFACTURING FACILITY. THE EVALUATION REVEALED THAT THE CATHETER CUFF REVEALED THAT ONLY PART OF THE CUFF WAS AFFECTED BY EXCESS ADHESIVE AND THAT THE OTHER PORTION OF THE CUFF REVEALED BLOOD AND TISSUE IMBEDDED IN THE CUFF. THE INVESTIGATION COULD NOT QUANTIFY THE SMOOTHNESS OF THE CUFF AS BEING RELATED TO THE LEVEL OF ADHESIVE USED IN THE CUFF ASSEMBLY. THEREFORE, BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED FOR THIS PARTICULAR REPORTED ISSUE. UNFORTUNATELY, A LOT NUMBER WAS NOT REC'D FOR THIS INCIDENT, THEREFORE, A REVIEW OF THE DEVICE HISTORY COULD NOT BE PERFORMED. A REVIEW OF ALL APPLICABLE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE IDENTIFIED FAILURE MODE. HOWEVER, PREVENTIVE ACTION HAS BEEN INITIATED IN WHICH, THE GLUING PROCESS USED TO BOND THE CUFF TO THE CATHETER HAS BEEN IMPROVED BY OPERATIONALIZING A QUANTITIVE CONTROL SPECIFICATION. INADDITION, ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL HAVE BEEN REC'D APPROPRIATE COMMUNICATIONS AND TRAINING TO HEIGHTEN AWARENESS OF THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    CATHETER BECAME DISLODGED AND REPORTEDLY CAUSED A PATIENT TO HAVE A PNEUMOTHORAX.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK