BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED VENOUS ACCESS CATHETER

    MDR report key: 965842 · Received December 12, 2007

    Report

    Report Number
    6000002-2007-05640
    Event Type
    Malfunction
    Date Received
    December 12, 2007
    Date of Event
    November 9, 2007
    Report Date
    November 12, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    JCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CLINICIAN DREW BACK SOLUTION FROM THE DISTAL LUMEN LINE, BUBBLES WERE OBSERVED. CUSTOMER QUESTIONED IF IT WAS ATTRIBUTED TO THE HEMOSTASIS VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED VENOUS ACCESS CATHETER CENTRAL VENOUS ACCESS CATHETER JCY EDWARDS LIFESCIENCES M3L9FHSI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other