BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFLEX TESIO CATHETER

    MDR report key: 1083016 · Received July 21, 2008

    Report

    Report Number
    2518902-2008-00025
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    April 3, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    PMA / PMN Number
    12
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECORD REVIEW. RECEIVED ONE VENOUS TESIO LUMEN. THE LUMEN WAS FRACTURED 1.26" FROM THE DISTAL TIP. THE EDGES OF THE BREAK ARE JAGGED. THE LUMEN INNER AND OUTER DIAMETERS WERE MEASURED AND FOUND TO MEET DESIGN SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS WHICH CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "CATHETER REMOVED IN MINI SURGERY, CATHETER END FRAGMENTED OFF AND MIGRATED. PATIENT WAS TRANSFERRED TO CARDIAC LAB FOR REMOVAL UNDER FLUOROSCOPE IN CATH LAB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOFLEX TESIO CATHETER HEMODIALYSIS CATHETER MSD MEDCOMP MFL-6 MAKQ270

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention