BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE BAG ACCESS DEVICE

    MDR report key: 21676683 · Received March 24, 2025

    Report

    Report Number
    MW5168009
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    March 17, 2025
    Report Date
    March 18, 2025
    Manufacturer
    BD SWITZERLAND SARL
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEVERAL SYRINGES FOUND WITH MISSING OR PARTIAL MARKINGS. BD 50ML SYRINGE #3 LOT:5017162, EXP:12/31/2029; BD 10ML SYRINGE #1 LOT: 5022493, EXP: 12/31/29. BD SMARTSITE BAG ACCESS DEVICE PORT BREAKS OFF WHILE ATTACHING SYRINGE. #2 LOT: 24045736, EXP: 04/26/27, 0 DEFECTED PRODUCTS WERE USED FOR PATIENT CARE. ALL DEFECTED ITEMS WERE DISPOSED OF IN THE MOMENT. NO PATIENTS AFFECTED. REFERENCE REPORTS: MW5168010, MW5168011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099987 BD SMARTSITE BAG ACCESS DEVICE SET, I.V. FLUID TRANSFER LHI BD SWITZERLAND SARL 24045736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BD 10ML SYRINGE| BD 50ML SYRINGE