BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 22891990 · Received August 26, 2025

    Report

    Report Number
    9616066-2025-02557
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    July 31, 2025
    Report Date
    September 17, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF A CHANGE IN THE INFUSION RATE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS TUBING FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    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 UNSPECIFIED BD INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT A CHANGE IN THE INFUSION RATE FROM 7ML/HR TO 5ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666197 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown