BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-LINK LUER ACTIVATED DEVICEWITH SILVER ANTIMICROBIAL COAT

    MDR report key: 1757078 · Received July 14, 2010

    Report

    Report Number
    6000001-2010-01394
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K081289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIFTEEN COMPANION UNITS WERE RECEIVED FOR EVALUATION PURPOSES RELATED TO CRACKED/ BROKEN CONDITION. UNITS WERE VISUALLY INSPECTED AND UNITS DID NOT PRESENT DEFECTS. UNITS RESULTS SATISFACTORY TO FUNCTIONAL TEST 0/15; TO CLEAR PASSAGE AT 8PSI 0/15, AND TO PRESSURE TEST AT 8PSI 0/15. THE REPORTED CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THEIR BAXTER SALES REPRESENTATIVE (BSR) THAT THE V-LINK LUER ACTIVATED DEVICE, PRODUCT CODE 6N8399, LOT NUMBER UR09A25048, IS CRACKING CAUSING LEAKS. THE FACILITY STARTED A V-LINK TRIAL IN THEIR TEN BED INTENSIVE CARE UNIT. THE BSR CALLED 09-MAR-2010 TO CHECK PROGRESS, THE CUSTOMER REPORTED THEY STOPPED USING THE PRODUCT DUE TO CRACKING. THIS INCIDENT OCCURRED BEFORE USE. THERE WAS NO PATIENT INJURY REPORTED. A SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-LINK LUER ACTIVATED DEVICEWITH SILVER ANTIMICROBIAL COAT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR09A25048

    Patients

    Seq Age Sex Outcome Treatment
    1