BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUTION SETS W/CAPLESS LUER ACTIVATED VALVE

    MDR report key: 601673 · Received May 9, 2005

    Report

    Report Number
    6000001-2005-01514
    Event Type
    Malfunction
    Date Received
    May 9, 2005
    Date of Event
    April 1, 2005
    Report Date
    April 18, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY'S NURSE REPORTED THAT LUER ACTIVATED VALVE IS CLOTTING ONCE ATTACHED, DURING PATIENT USE. THE PATIENT HAD A PERIPHERAL IV ACCESS, WHICH WAS BEING USED FOR AN INTERMITTENT ADMINISTRATION OF ANTIBIOTICS. THE PATIENT WAS RECEIVING CIPRO EVERY 8 HOURS, ANCEF EVERY 8 HOURS, AND VANCOMYCIN EVERY 12 HOURS. THERE WERE NBO CONTINUOUS INFUSIONS BEING ADMINISTERED TO THE PATIENT. THE VALVE WAS CONNECTED DIRECTLY TO THE ANGIO-CATHETER AND REPORTEDLY, IT WAS NOT BEING LOCKED WITH HEPARIN OR SALINE. THE VALVE WAS FOUND CLOTTING OFF UPON FLUSHING FOR ANTIPATRIOTIC INFUSION. THERE WAS NO FLOW AND ONCE THE VALVE WAS REMOVED, IT WAS DISCOVERED THAT THE LINE CLOTTED OFF. A NEW IV HAD TO BE STARTED. NO PATIENT INJURY OCCURRED AND NO MEDICAL INTERVENTION WAS NEEDED. REPORTEDLY, THE EVENT OCCURRED TWICE ON THE SAME PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLUTION SETS W/CAPLESS LUER ACTIVATED VALVE SOLUTION ADMINISTRATION SET FPA BAXTER HEALTHCARE CORPORATION NA UR252817

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN