BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS CATHETER INSERTION TRAY WITH 8 FRENCH INTRODUCER

    MDR report key: 1220846 · Received October 28, 2008

    Report

    Report Number
    6000002-2008-09089
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYB
    PMA / PMN Number
    K831729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE TWO DEVICES RETURNED AND BOTH SAMPLES WERE EVALUATED. CUSTOMER REPORT WAS CONFIRMED ON BOTH DEVICES. THE TOUHY BORST TYPE INTRODUCER WAS RECEIVED BROKEN IN HALF AT THE BOTTOM OF THE THREADED AREA OF THE HOUSING. THE INTRODUCER WAS RETURNED WITH A NON EDWARDS PACING TYPE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "SCREW-CAP" WAS BROKEN ON 2 DEVICES. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS CATHETER INSERTION TRAY WITH 8 FRENCH INTRODUCER PERCUTANEOUS CATHETER INTRODUCER DYB EDWARDS LIFESCIENCES, PR I451BF6 58562341

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK