BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS EXTENSION SET

    MDR report key: 21068794 · Received January 3, 2025

    Report

    Report Number
    9616066-2024-02172
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 11, 2024
    Report Date
    December 17, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403233647
    PMA / PMN Number
    K790108
    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

    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 BD ALARIS EXTENSION SET WAS OCCLDUED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT DURING ONSITE ROUNDING AT OSU WEXNER MEDICAL INFUSION CENTERS (OUTPATIENT AND IN-PATIENT) ON (B)(6) 2024, NURSES (BECKI AND KRISTIN) REPORTED THAT THE AS NOTED ABOVE AND IN THE PHOTO OF THE PACKAGE INSERT THE BD EXTENSION SET SMALLBORE TUBING 0.2 MICRON LOW PROTEIN BINDING FILTER REF (B)(4) WERE CLOGGING DURING INFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640111 BD ALARIS EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 10885403233647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown