BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10F X 24CM SPLIT CATH

    MDR report key: 4253165 · Received November 13, 2014

    Report

    Report Number
    2518902-2014-00069
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    September 24, 2014
    Report Date
    November 12, 2014
    Manufacturer
    MEDCOMP
    Product Code
    JCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. THE RETURNED DEVICE WAS FORWARDED TO THE MFG FACILITY FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE TUNNELER GETS SEVERELY BENT AND ENDS UP LEAVING PIECES OF THE SHEATH IN THE PT. HANDLE OF PEEL AWAY SHEATH SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733090 10F X 24CM SPLIT CATH HEMODIALYSIS CATHETER JCY MEDCOMP ASPC24P-XL MGFK350

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention