BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16F X 24CM SPLIT CATH III

    MDR report key: 1930141 · Received November 18, 2010

    Report

    Report Number
    2518902-2010-00072
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 19, 2010
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. WE ARE CURRENTLY WAITING FOR THE RETURN OF THE DEVICE SAMPLE FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TESTING OF THE CATHETER AFTER INSERTION, A HOLE WAS FOUND IN THE ARTERIAL EXTENSION REQUIRING CATHETER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 16F X 24CM SPLIT CATH III HEMODIALYSIS CATHETER MSD MEDCOMP AAC23601 MBAS560

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR