BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPUT PS

    MDR report key: 1604212 · Received February 4, 2010

    Report

    Report Number
    1604212
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    January 13, 2010
    Report Date
    February 4, 2010
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A FEMORAL IV SITE WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN. AT THE END OF THE CASE THE FEMORAL IV SITE WAS INSPECTED AND IT WAS FOUND TO HAVE BLOOD LEAKING FROM THE HUB OF THE IV WHICH RESULTED IN PATIENT BLOOD LOSS AND A DROP IN THE PATIENT'S HEMATOCRIT.THE HUB OF THE IV CRACKED AND RESULTED IN BLOOD LOSS. THE CRACKED AREA IS NOT AT AN AREA THAT NEEDS TO BE ATTACHED OR MANUALLY TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INPUT PS INTRODUCER, CATHETER, PERCUTANEOUS DYB MEDTRONIC VASCULAR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR