BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 14283054 · Received May 4, 2022

    Report

    Report Number
    1416980-2022-02232
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    March 29, 2022
    Report Date
    June 2, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOGUE AND LOT NUMBER: THE CUSTOMER INDICATED THE PRODUCT CODE WAS 2C8541 AND THE LOT # IS R21D09024; HOWEVER, LOT # R21D09024 IS ASSOCIATED WITH PRODUCT CODE 2H8671 THE USER FACILITY SUBMITTED MEDWATCH 0700220000-2022-8063 FOR THIS EVENT. (B)(4). 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, PREVIOUSLYS SUBMITTED AS ¿UNKNOWN BAXTER ACCESS SET¿. D1: THE BRAND OF THE AFFECTED PRODUCT IS ¿CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET¿, PREVIOUSLY SUBMITTED AS ¿NI¿. D4: CATALOGUE #: ¿2C8541¿, PREVIOUSLY SUBMITTED AS ¿ASKU¿. D4: LOT #: ¿R22B22086¿, PREVIOUSLY SUBMITTED AS ¿ASKU¿. D4: UDI #: (B)(4), PREVIOUSLY SUBMITTED AS ¿NI¿. G4: 510K #: ¿K203609¿, PREVIOUSLY SUBMITTED AS ¿NI¿. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING OF AN UNKNOWN BAXTER ACCESS SET LEAKED FROM A SMALL HOLE. THIS WAS IDENTIFIED DURING UNSPECIFIED PROCESS STEP. 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
    667043 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA R22B22086

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown