BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO-VENT CLEARLINK LUER ACTIVATED VALVE

    MDR report key: 15501863 · Received September 29, 2022

    Report

    Report Number
    1416980-2022-05139
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    August 17, 2022
    Report Date
    October 26, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CATALOGUE #: THE PRODUCT CODE OF THE DEVICE WAS REPORTED TO BE EITHER 2R8875 OR 2C8875. DEVICE MANUFACTURER ADDRESS 1: (B)(4). 510K #: 2R8875 HAS A 510K # OF K180739. 2C8875 HAS A 510K # OF K112893. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLEARLINK SOLUTION SET LEAKED UNDER THE HOOD DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955561 DUO-VENT CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown