BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL CATHETER EXT SET/LUER ACT.VALVE MLL ADAPTER

    MDR report key: 1830308 · Received September 10, 2010

    Report

    Report Number
    6000001-2010-03097
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED DUE TO NO SAMPLES BEING AVAILABLE FOR EVALUATION. SHOULD SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OF IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS IS THE REPORT FOR OCCURRENCE 2 OF 2 REPORTED UNDER MDR 6000001-2010-01166.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THEIR BAXTER SALES REPRESENTATIVE (BSR) OF AN OCCURRENCE WHERE THE CLEARLINK LUER OF THE CLEARLINK CATHETER EXTENSION SET POPS OFF. THE BSR VISITED THE FACILITY AND INFORMED THE STAFF THAT PER THE LABEL COPY, THE LUER CONNECTIONS ARE TO BE TIGHTENED/SECURED BEFORE USE. THE STAFF WAS UNAWARE OF THIS PRIOR. THE PROBLEM DOES NOT OCCUR WHEN THE PRODUCT IS INITIALLY USED ON THE PATIENT, BUT AFTER AN UNKNOWN AMOUNT OF TIME. THERE ARE NO SAMPLES AVAILABLE. THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL CATHETER EXT SET/LUER ACT.VALVE MLL ADAPTER SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1