BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK PACLITAXEL SETS

    MDR report key: 18635669 · Received February 2, 2024

    Report

    Report Number
    1416980-2024-00314
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    November 7, 2023
    Report Date
    March 19, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K153158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D1: BRAND NAME: CLEARLINK PACLITAXEL SETS (PREVIOUSLY SUBMITTED AS CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS) CORRECTION MADE TO D4: CATALOGUE #: 2R8858 (PREVIOUSLY SUBMITTED AS 2H8480) CORRECTION MADE TO D4: LOT #: NI (PREVIOUSLY SUBMITTED AS R23D25079) CORRECTION MADE TO G4 PMA/510K # OR BLA #: K160007 (PREVIOUSLY SUBMITTED AS K153158) ADDITIONAL INFORMATION WAS ADDED TO B5, H6, AND H10: B5: THE DEVICE IS A CLEARLINK PACLITAXEL SET. 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 A CLEARLINK SYSTEM NON DEHP SOLUTION SET LEAKED AT THE LOWER PORT. THIS WAS OBSERVED PRIOR TO HANGING THE SUPPLIES FOR THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248768 CLEARLINK PACLITAXEL SETS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA R23D25079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown