BEUDAMED
    FDA Adverse Event Other Summary report: N

    DECATHLON

    MDR report key: 1660336 · Received December 18, 2009

    Report

    Report Number
    1223643-2009-00006
    Event Type
    Other
    Date Received
    December 18, 2009
    Date of Event
    August 14, 2009
    Report Date
    December 16, 2009
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Product Code
    MSD
    PMA / PMN Number
    K032061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE IS ATTRIBUTED TO "USER ERROR." THE DEVICE WAS NOT RETURNED FOR TESTING AND EVALUATION. A FULL INVESTIGATION ON RETURNED PRODUCT FROM THE SAME FACILITY WAS PREVIOUSLY PERFORMED RESULTING IN TWO REPORTS FILED WITH THE FDA. THE CATHETER INVOLVED IN THIS INCIDENT WAS REPORTED AS "STILL FUNCTIONING" AT THE TIME OF THE LAST REPORTS. TESTING RESULTS ARE AVAILABLE FROM THE PREVIOUS INVESTIGATIONS AND ARE ATTACHED. A REPAIR KIT IS AVAILABLE FOR USE WITH THIS CATHETER AND WAS NOT USED. A "HEMACLIP" DEVICE THAT IS NOT MANUFACTURED BY SPIRE BIOMEDICAL WAS USED ON THIS CATHETER AS WELL AS THE OTHERS PREVIOUSLY REPORTED. A SAMPLE OF THIS DEVICE WAS RECEIVED DURING THE PREVIOUS INVESTIGATION. IT IS A SEMI-RIGID PLASTIC DEVICE THAT APPLIES RADIAL AND AXIAL PRESSURE ON THE LUERS. THIS PRESSURE COUPLED WITH THE CLEANING AGENT LIKELY PUT UNDUE STRESS ON THE LUER, CAUSING IT TO FAIL. THE CLINIC WAS USING IODINE AND SWITCHED TO EXSEPT PLUS.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED A COPY OF MEDWATCH REPORT # (B)(4) VIA MAIL ON (B)(4) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DECATHLON MSD (LONG TERM HEMODIALYSIS CATHETER) MSD SPIRE BIOMEDICAL, INC. DE23SH28-K 99607981

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention