BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 14488608 · Received May 24, 2022

    Report

    Report Number
    1416980-2022-02610
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 27, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE NO. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B5: THE AFFECTED PRODUCT IS "CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET"; PREVIOUSLY SUBMITTED AS "UNSPECIFIED PRIMARY IV (INTRAVENOUS) TUBING SET". D1: THE UPDATE TO BRAND NAME IS "CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET"; PREVIOUSLY SUBMITTED AS NI D4: THE UPDATE TO PRODUCT CODE IS "2C8541"; PREVIOUSLY SUBMITTED AS ASKU G1: THE UPDATED MANUFACTURING FACILITY IS BAXTER HEALTHCARE - CARTAGO 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL CARTAGO COSTA RICA 30106 G4: THE 510K # IS "K203609"; PREVIOUSLY SUBMITTED AS "NA" 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONNECTOR OF AN UNSPECIFIED PRIMARY IV (INTRAVENOUS) TUBING SET WAS FOUND TO BE COMPLETELY SMASHED. THIS WAS OBSERVED AFTER PRIMING THE SET WITH MEDICATION WHEN THE NURSE REMOVED THE CAP. 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
    1473965 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown