BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE LOW SORBING SECONDARY SET

    MDR report key: 25263143 · Received May 22, 2026

    Report

    Report Number
    9616066-2026-01363
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    February 3, 2026
    Report Date
    May 11, 2026
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403221934
    PMA / PMN Number
    K022209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER FACILITY NAME: (B)(6). H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE LOW SORBING SECONDARY SET HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2026 CARFILZOMIB MADE FOR PT CORRECTLY. RN UNABLE TO BACK PRIME 2RY SET. TUBING APPEARS TO HAVE CRIMP IN IT WILL NOT ALLOW FLUID TO FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527170 BD ALARIS SMARTSITE LOW SORBING SECONDARY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. UNKNOWN 10885403221934

    Patients

    Seq Age Sex Outcome Treatment
    1