BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO-VENT CLEARLINK LUER ACTIVATED VALVE

    MDR report key: 17309063 · Received July 12, 2023

    Report

    Report Number
    1416980-2023-03513
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 16, 2023
    Report Date
    November 21, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS TO D1, D4, G1, G4, D1: BRAND NAME: REMOVE: CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS. D4: CATALOGUE #: REMOVE: 2H8480. D4: LOT #: THE CUSTOMER REPORTED TWO POTENTIAL LOT NUMBERS: (B)(6) (OMITTED ON INITIAL REPORT). G1: DEVICE MANUFACTURER NAME: REMOVE: BAXTER HEALTHCARE ¿ CARTAGO. G1: DEVICE MANUFACTUER ADDRESS: REMOVE: 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL. G1: DEVICE MANUFACTURER CITY: REMOVE: CARTAGO. G1: DEVICE MANUFACTURER COUNTRY: REMOVE: COSTA RICA. G1: DEVICE MANUFACTURER POSTAL CODE: REMOVE 30106. G4 510K: REMOVE K153158. ADDITIONAL INFORMATION ADDED TO H6, AND H10. H10: A BATCH REVIEW WAS CONDUCTED ON THE TWO POTENTIAL LOT NUMBERS AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE LOTS .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.

    Additional Manufacturer Narrative · 0

    G1: DEVICE MANUFACTURER ADDRESS 1: 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM NON DEHP SOLUTION SET LEAKED. THERE APPEARED TO BE SMALL HOLES IN THE TUBING. THIS WAS IDENTIFIED DURING PRIMING WITH PROPOFOL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802989 DUO-VENT CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown