BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP INFUSION SET

    MDR report key: 22235598 · Received June 17, 2025

    Report

    Report Number
    MW5171589
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    June 6, 2025
    Report Date
    June 6, 2025
    Manufacturer
    BD / BD SWITZERLAND SÀRL
    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

    RN PULLED A BD ALARIS PUMP INFUSION SET REF NUMBER 2420-0007 LOT NUMBER 25035293 EXPIRATION DATE OF 2028-03-09 AND UPON PRIMING NOTICED A WEAKEN AREA AT TUBING WHICH CAUSED TUBING TO BUBBLE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28515 BD ALARIS PUMP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BD / BD SWITZERLAND SÀRL 2420-0007 25035293

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown