BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PRIMARY PUMP INFUSION SET PVC

    MDR report key: 24146797 · Received January 22, 2026

    Report

    Report Number
    MW5182641
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 15, 2026
    Report Date
    January 16, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE SPIKING A 500 ML NS BAG WITH AN ALARIS PRIMARY LINE, A THIN, [INVALID]LIKE FOREIGN OBJECT (~0.5 CM) WAS OBSERVED FLOATING IN THE PRIMARY LINE FROM THE NS BAG. PRODUCT QUARANTINED. NS BAG MANUFACTURER: B. BRAUN, REF L8001, LOT J5H678, EXP 2027-11. BD ALARIS PRIMARY PUMP INFUSION SET PVC REF 2420-0007, LOT 25095682, MANUFACTURE 09-22-2025 EXPIRATION DATE 09-21-2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215580 BD ALARIS PRIMARY PUMP INFUSION SET PVC SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON 2420-0007 25095682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SODIUM CHLORIDE 0.9% 500ML BAG.