BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 22955971 · Received September 3, 2025

    Report

    Report Number
    9616066-2025-02650
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 7, 2025
    Report Date
    October 30, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE OF EVENT IS UNKNOWN; BD AWARENESS DATE USED. E.1. ADDRESS WAS NOT LOCATED, AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION/DISCONNECTION TEST SHOWED THAT ALTHOUGH ALL THE DEVICES COMPLIED WITH THE CURRENT STANDARD, THERE WAS A STATISTICALLY SIGNIFICANT DIFFERENCE IN THE MEAN ±STANDARD DEVIATION COMPRESSION FORCE (51.5 ±11.6 FOR THE CONNECT-ZTM VS. 60.3±11.7 FOR THE CHEMOLOCKTM; P=0.0005). THE CONTAMINATION RATES WERE SIGNIFICANTLY DIFFERENT: (B)(4) FOR THE BD PHASEALTM VERSUS (B)(4) FOR THE CHEMOLOCKTM; P < 0.0001).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734103 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