BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 23658103 · Received November 26, 2025

    Report

    Report Number
    1416980-2025-05864
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Report Date
    January 12, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1/D4/G4: THE SET IS POTENTIALLY ONE OF THE FOLLOWING: BRAND NAME IS CLEARLINK/CONTINU-FLO, MODEL AND CATALOG NUMBER 2C8537, UDI# IS (B)(4), 510K# IS K203609. BRAND NAME IS CLEARLINK, MODEL AND CATALOG NUMBER 2C8425, UDI# IS (B)(4), 510K# IS K112893. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 (UPDATE CODES), H11. H11: 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 ACCESS SET HAD BUBBLES STAYING IN THE PORT SIDE. THIS WAS OBSERVED AFTER PRIMING THE TUBING. 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
    2672079 ASKU SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION ASKU NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown