BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EXTENSION SET

    MDR report key: 21845335 · Received April 15, 2025

    Report

    Report Number
    9616066-2025-00915
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 21, 2025
    Report Date
    July 17, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K171957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Additional Manufacturer Narrative · 0

    NO PHOTO OR SAMPLE WAS RECEIVED FOR THE CUSTOMER'S COMPLAINT OF SEPARATION/ FLOW ISSUES. THE MANUFACTURER HAS BEEN NOTIFIED OF THIS OCCURRENCE. THE PRODUCTION HISTORY WAS ANALYZED AND THERE WERE NO ISSUES FOUND DURING QUALITY INSPECTIONS THAT WOULD LEAD TO THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. WE HAVE HAD MULTIPLE COMPLAINTS REGARDING THE BD MAXZERO EXTENSION SETS SEPARATING FROM THE HUB AND DIFFICULTY FLUSHING THE IV. RADIOLOGY HAS REPORTED THAT WHEN CT USES THE PRESSURE INJECTOR TO ADMINISTER CONTRAST, THE SET DISCONNECTS AND LEAKS. IN ADDITION, STAFF REPORTS INCREASED DIFFICULTY FLUSHING IV'S IN THE ED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340365 BD EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 25019207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown