BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS

    MDR report key: 24689747 · Received March 25, 2026

    Report

    Report Number
    MW5185850
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 19, 2026
    Report Date
    March 23, 2026
    Manufacturer
    BD SWITZERLAND SARL
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT REF # (B)(4), LOT (10)24109018 EXP: 10-02-2027 - 2 REPORTS OF LEAKING AROUND CONNECTOR. THE CONNECTOR WAS FOUND TO BE TIGHT. THIS WAS FOUND DURING A DOXORUBICIN INFUSION AND WAS NOTICED DUE TO THE RED COLOR. THERE WAS A SCANT AMOUNT OF FLUID BOTH TIMES. REFERENCE REPORT#: MW5185851.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745385 LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS SET, I.V. FLUID TRANSFER LHI BD SWITZERLAND SARL 70001B-07T (10) 24109018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SMARTSITE BAG ACCESS NON-VENTED