BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15F VALVED PEELABLE INTRODUCER

    MDR report key: 2241442 · Received August 18, 2011

    Report

    Report Number
    2518902-2011-00083
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    April 28, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDCOMP
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WE ARE CURRENTLY WAITING FOR THE RETURN OF THE DEVICE FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "WHEN INSERTING THE PEEL AWAY DILATORS FOR THE TUNNELIZED CATHETER. THE CHECK VALVE LET THE BLOOD FLOWS THROUGH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15F VALVED PEELABLE INTRODUCER VALVED PEELABLE INTRODUCER DYB MEDCOMP MCVSI15FG MAKF970

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK