BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTASIS VALVE INTRODUCERS

    MDR report key: 1062677 · Received June 16, 2008

    Report

    Report Number
    6000002-2008-07574
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYB
    PMA / PMN Number
    K981909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVAL, IT WAS DISPOSED AT THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTION BETWEEN THE AVA CATHETER BODY AND THE CONTAMINATION SHIELD GOT BROKEN OFF. FOLLOWED UP WITH THE CUSTOMER, INDICATED THAT IT WAS BROKEN AT THE CONNECTION DURING INSERTION. CONFIRMED THAT THERE WERE NO PT INJURY OR COMPLICATIONS. DEVICE WAS DISCARDED AT HOSPITAL AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTASIS VALVE INTRODUCERS AVA3XI-ADVANCED VENOUS ACCESS DEVICES DYB EDWARDS LIFESCIENCES, PR M3L9FHKIN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other