BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL SYSTEM CATHETER EXT SET/LUER ACTIVATED VALVE FOR IV ACCES

    MDR report key: 1941526 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06365
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER SENT IN THREE ACTUAL CLEARLINK EXTENSION SETS AND THREE ACTUAL ELCAM STOPCOCK SAMPLES FOR EVALUATION. EACH CLEARLINK VALVE WAS REMOVED FROM THE STOPCOCK AND THESE SAMPLES WERE VISUALLY INSPECTED FOR THE PRESENCE OF THE CENTER SLIT, AND FOR ANY ABNORMALITIES. THERE WERE NO VISUAL ABNORMALITIES DISCOVERED FROM THESE SAMPLES. THE CLEARLINK VALVE WAS THEN RE-ATTACHED TO THE STOPCOCK WHICH WAS THEN ATTACHED TO AN IN-HOUSE SECONDARY MEDICATION SET SPIKED INTO A 500 ML SOLUTION BAG CONTAINING REVERSE OSMOSIS WATER. ALL THREE SAMPLES WERE THEN RE-PRIMED AND CHECKED FOR FLOW. ALL THREE SAMPLES PRIMED AND FLOWED NORMALLY. PER THIS EVALUATION, THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE BATCH REVIEW COULD NOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO A BAXTER SALES REPRESENTATIVE OF A NO FLOW OCCURRING WITH A CLEARLINK EXTENSION SET WHEN IT IS CONNECTED IN CONJUNCTION WITH AN ELCAM FOUR-WAY STOPCOCK . THIS REPORTED CONDITION OCCURRED DURING PATIENT-USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL SYSTEM CATHETER EXT SET/LUER ACTIVATED VALVE FOR IV ACCES SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 ELCAM 4 WAY STOPCOCK, UNKNOWN SOLUTION