BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14F X 28CM SPLIT CATH III

    MDR report key: 1930150 · Received November 18, 2010

    Report

    Report Number
    2518902-2010-00074
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    September 24, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS AND PROCESSES WERE REVIEWED. NO NON-CONFORMANCES WERE NOTED. ALL PARTS ARE 100% LEAK TESTED IN-PROCESS. THE PRODUCT INCIDENT REPORT NOTED THAT THIS CATHETER WAS IMPLANTED AND FUNCTIONED WITHOUT INCIDENT FOR OVER FOUR YEARS. WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REGULAR DIALYSIS TREATMENT, THE LINES WERE FLUSHED WITH NO PROBLEMS NOTED. WHEN CONNECTED TO THE MACHINE, THE ARTERIAL LINE SEEMED TO BE SUCKING AIR. FULL CIRCUIT CHECKED FOR ANY LOOSE CONNECTIONS. THE LINES WERE REVERSED AND BLOOD WAS FOUND OOZING FROM THE EXIT SITE. A SMALL CRACK WAS NOTED ON THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14F X 28CM SPLIT CATH III HEMODIALYSIS CATHETER MSD MEDCOMP ASPC28-3E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention