BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTASIS VALVE INTRODUCERS

    MDR report key: 1220808 · Received October 30, 2008

    Report

    Report Number
    6000002-2008-09133
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYB
    PMA / PMN Number
    K981909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. CUSTOMER REPORT WAS CONFIRMED. THE OPEN TRAY WAS RECEIVED WITH THE PRODUCT UNUSED. THE TRAY WAS FOUND TO HAVE WHAT APPEARS TO BE A CLEAR OILY SUBSTANCE ON THE BOTTOM OF THE TRAY. THE TRAY WAS SENT TO CHEMISTRY FOR TESTING, AND THE SUBSTANCE WAS DETERMINED TO BE CONSISTENT WITH SILICON OIL. THIS SUBSTANCE IS USED TO LUBRICATE THE VALVE ON THE CATHETER DURING MANUFACTURING, AND HAS APPARENTLY BEEN USED IN EXCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SLIPPERY OILY SUBSTANCE INSIDE THE TRAY WHEN THE PHYSICIAN OPENED THE PACKAGE. IT WAS FURTHER STATED THAT THE PHYSICIAN CLEARLY RECOGNIZED THE SUBSTANCE. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTASIS VALVE INTRODUCERS AVA3XI - ADVANCED VENOUS ACCESS DEVICES DYB EDWARDS LIFESCIENCES, PR M3L9FHKI 58549266

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other