BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-FLEX TESIO CATHETER

    MDR report key: 1960427 · Received December 16, 2010

    Report

    Report Number
    2518902-2010-00083
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    September 30, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    PMA / PMN Number
    12
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MFG RECORDS INDICATED ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER "ELECTIVE NECKLINE REMOVAL, SPLIT WAS SEEN BELOW THE ARTERIAL CUFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-FLEX TESIO CATHETER HEMODIALYSIS CATHETER MSD MEDCOMP BFS-6SE MAQG820

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR