BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK LUER ACTIVATED VALVE

    MDR report key: 14621795 · Received June 7, 2022

    Report

    Report Number
    1416980-2022-02944
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 13, 2022
    Report Date
    July 11, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412656649
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO G1: DEVICE MANUFACTURER NAME: BAXTER HEALTHCARE - DOMINICAN REPUBLIC (PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE - HAINA). CORRECTION MADE TO G1: DEVICE MANUFACTURER ADDRESS 1: CARRETERA SANCHEZ KM 18.5 (PREVIOUSLY SUBMITTED AS PIISA INDUSTRIAL PARK ANTIGUA). CORRECTION MADE TO G1: DEVICE MANUFACTURER ADDRESS 2: PARQUE INDUSTRIAL ITABO, PIISA (PREVIOUSLY SUBMITTED AS CARRETERA SANCHEZ KM 18 1/2). H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WAS LEAKING FROM THE BASE OF THE PRIMING CHAMBER WHERE THE TUBING INSERTS OR CONNECTS TO THE PRIMING CHAMBER. THE LEAK WAS DISCOVERED IN THE CLEANROOM PRIOR TO DISPENSING OR PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577795 CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA DR21H20031 00085412656649

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown