BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR KIT

    MDR report key: 1934715 · Received November 24, 2010

    Report

    Report Number
    2518902-2010-00076
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDCOMP
    Product Code
    NFK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. WE ARE CURRENTLY WAITING FOR ADDITIONAL INFORMATION AND THE RETURN OF THE DEVICE SAMPLE FOR EVALUATION, IF AVAILABLE. WHEN THE INVESTIGATION IS COMPLETE A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX 15-20 MINUTES INTO THE DIALYSIS TREATMENT THE "CONNECTOR HAD SHEARED OUT CAUSING VENOUS LINE TO SPILL BLOOD." DIALYSIS WAS DISCONTINUED, LINES CLAMPED. NO OBVIOUS HARM TO PT. DOCTOR WAS CONTACTED AND THE LINE WAS REPAIRED. LINE NEEDS TO BE REPLACED, AWAITING ANGIO INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR KIT REPAIR KIT NFK MEDCOMP RPK-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DIALYSIS CATHETER