BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO-VENT CLEARLINK LUER ACTIVATED VALVE

    MDR report key: 14916259 · Received July 5, 2022

    Report

    Report Number
    1416980-2022-03470
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Report Date
    August 25, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K180739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    ADDITIONAL INFORMATION WAS ADDED TO B5, D1, D4: (CATALOGUE #), G1: DEVICE MANUFACTURER NAME, G4, 510K #, H6 AND H10. B5: THE EFFECTED PRODUCT WAS ¿CLEARLINK SYSTEM, SOLUTION SET¿, PREVIOUSLY SUBMITTED AS ¿UNSPECIFIED INTRAVENOUS TUBING¿. D1: THE BRAND NAME OF THE AFFECTED PRODUCT WAS ¿DUO-VENT CLEARLINK LUER ACTIVATED VALVE¿, PREVIOUSLY SYBMITTED AS ¿NI¿. D4: THE CATALOGUE # IS ¿2R8875¿, PREVIOUSLY SUBMITTED AS ¿ASKU¿. G1: DEVICE MANUFACTURER NAME: ¿BAXTER HEALTHCARE ¿ CARTAGO¿, PREVIOUSLY SUBMITTED ¿BAXTER HEALTHCARE CORPORATION¿. G1: DEVICE MANUFACTURER ADDRESS 1: 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL. G4: 510K #: ¿K180739¿, PREVIOUSLY SUBMITTED AS ¿NI. H10: THE DEVICES WERE 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: THE DEVICES WERE 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 AN UNSPECIFIED QUANTITY OF INTRAVENOUS TUBING HAD EXCESSIVE AIR IN TUBING. THE DEVICES WERE FILLED WITH CHEMOTHERAPY/HAZARDOUS DRUGS. THE ISSUE WAS IDENTIFIED DURING PRODUCT USE. THE TUBING WAS DISPENSED FROM THE PHARMACY WITH NO ISSUES NOTED. WHEN THE NURSES TRIED TO INFUSE, THE LINE WOULD HAVE LARGE AMOUNTS OF AIR. 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
    376641 DUO-VENT CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CHEMOTHERAPY/HAZARDOUS DRUGS.