BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.5FX 15CM HEMO-CATH

    MDR report key: 3902574 · Received May 9, 2014

    Report

    Report Number
    2518902-2014-00032
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDCOMP
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE 11.5F X 15CM SILICONE DOUBLE LUMEN CATHETER FOR EVALUATION. A VISUAL INSPECTION OF THE CATHETER REVEALS NO OUTWARD PHYSICAL DAMAGE. A FUNCTIONAL EVALUATION OF THE CATHETER REVEALS THE VENOUS EXTENSION HAS A PIN HOLE LEAK APPROXIMATELY 0.4CM BELOW THE EXTENSION OVERMOLDED SLEEVE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. THE EXTENSIONS WERE CROSS SECTIONED AND MEASURED. ALL MEASUREMENTS WERE WITHIN THE DESIGN SPECIFICATIONS. THIS FAMILY OF DEVICES IS 100% LEAK TESTED PRIOR TO RELEASE. WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS WHICH MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    ATTEMPTING DIALYSATE PATIENT WITH TEMP. HD CATH IN R FEM VEIN LINES REVERSED FOR BETTER FLOW. THIRTY MINUTES INTO IT I WENT TO FLUSH BLUE LUMEN AND NOTICED A TINY HOLE ALLOWING BLOOD TO FLOW OUT AND AIR TO FLOW IN UNDER PRESSURE. BLOOD RETURNED AND TERMINATED, CHANGED WITH NEW TEMP. CATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282346 11.5FX 15CM HEMO-CATH HEMODIALYSIS CATHETER LFJ MEDCOMP MCDLTSL15 MBKB990

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention