BEUDAMED
    FDA Adverse Event Other Summary report: N

    DECATHLON

    MDR report key: 1511491 · Received October 14, 2009

    Report

    Report Number
    1223643-2009-00004
    Event Type
    Other
    Date Received
    October 14, 2009
    Date of Event
    September 1, 2009
    Report Date
    October 9, 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

    A REPAIR KIT IS AVAILABLE FOR USE WITH THIS CATHETER AND WAS NOT USED. THE COMPLETE DEVICE WAS NOT RETURNED FOR EVALUATION AND TESTING ONLY THE BLUE LUER WAS RETURNED. A "HEMACLIP" DEVICE THAT IS NOT MANUFACTURED BY SPIRE BIOMEDICAL WAS USED ON THE DEVICE AND WAS ALSO RECEIVED. THIS IS A SEMI-RIGID PLASTIC DEVICE THAT APPLIES RADIAL AND AXIAL PRESSURE ON THE LUERS. THIS PRESSURE COUPLED WITH THE CLEANING AGENT PUT UNDUE STRESS ON THE LUER, CAUSING IT TO FAIL. THE CLINIC WAS USING IODINE AND SWITCHED TO EXSEPT PLUS. THE FAILURE IS ATTRIBUTED TO "USER ERROR." SEE THE ATTACHED PRODUCT INCIDENT REPORT FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED "PT 1" HAD A BLUE CRACKED LUER AND THE CATHETER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DECATHLON MSD (LONG TERM HEMODIALYSIS CATHETER) MSD SPIRE BIOMEDICAL, INC. DE23SH28 99568752

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention