BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 13334485 · Received January 24, 2022

    Report

    Report Number
    1416980-2022-00123
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    January 2, 2022
    Report Date
    May 16, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (MANUFACTURING FACILITY), G4. EVENT: THE AFFECTED PRODUCT IS ¿CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET¿, PREVIOUSLY SUBMITTED AS ¿UNSPECIFIED ACCESS SETS¿. BRAND NAME: CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET, PREVIOUSLY SUBMITTED AS "NI". CATALOGUE #: ¿2C8541¿, PREVIOUSLY SUBMITTED AS ¿ASKU¿. DEVICE MANUFACTURER ADDRESS 1: 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL (ADDRESS, CITY, STATE, PREVIOUSLY SUBMITTED AS "NI". 510K #: ¿K203609¿, PREVIOUSLY SUBMITTED AS ¿NI¿. 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

    H10: THREE (3) DEVICES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED INCLUDING CLEAR PASSAGE AND PRESSURE TESTING AND THERE WERE NOT ISSUES NOTED. PRIMING WAS ALSO PERFORMED, WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO (2) UNSPECIFIED ACCESS SETS WERE LEAKING FROM THE PORT. THE ISSUE WAS IDENTIFIED DURING MULTIPLE STEPS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936577 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown