BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCED VENOUS ACCESS CATHETER

    MDR report key: 1001445 · Received February 14, 2008

    Report

    Report Number
    6000002-2008-06053
    Event Type
    Other
    Date Received
    February 14, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE A BLUE INK PEN WAS FOUND WRAPPED ON TOP INSIDE THE STERILE PACKAGE. IT WAS NOTICED BY THE NURSE BECAUSE THE PACKAGE WAS NOT FLAT ON THE BOTTOM; COULDN'T SET PACK FLAT ON DR'S TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED VENOUS ACCESS CATHETER CENTRAL VENOUS ACCESS CATHETER DQO EDWARDS LIFESCIENCES, PR M3L9FKIC 58427858

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other