BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15.5F X 15CM IJ FREE FLOW

    MDR report key: 1160015 · Received September 12, 2008

    Report

    Report Number
    2518902-2008-00032
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    July 7, 2008
    Report Date
    September 12, 2008
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PORTION OF ONE 15.5FX 15CM FREE FLOW CATHETER WAS RETURNED. THE BLUE FEMALE LUER IS SEPARATED FROM THE EXTENSION TUBING. THERE IS VISIBLE DAMAGE ON THE STEM OF THE BLUE FEMALE LUER. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. THE RETURNED SAMPLE WAS FORWARDED TO THE MANUFACTURER FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAP OF THE LUER GOT LOOSE. THE CATHETER WAS IN USE SINCE 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15.5F X 15CM IJ FREE FLOW HEMODIALYSIS CATHETER-FREE-FLOW MSD MEDCOMP JFFS1515IJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK