BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP INFUSION SET IV TUBING/ACCESSORIES

    MDR report key: 22771861 · Received August 11, 2025

    Report

    Report Number
    MW5174316
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 6, 2025
    Manufacturer
    BD SWITZERLAND SARL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BD ALARIS PUMP INFUSION SET MANUFACTURED 2025-03-21 WITH EXPIRATION DATE OF 2028-03-20, LOT 25035496 IN 2 PIECES WHEN REMOVED FROM PLASTIC WRAPPER. UNABLE TO USE AND REMOVED FROM PATIENT CARE AREA. REPORTED TO SUPERVISOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271020 PUMP INFUSION SET IV TUBING/ACCESSORIES SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SARL 2420-0007 25035496

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown