BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URINARY DRAINAGE BAG

    MDR report key: 23778386 · Received December 11, 2025

    Report

    Report Number
    23778386
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 25, 2025
    Manufacturer
    C. R. BARD, INC.
    Product Code
    KNX
    UDI-DI
    801741029608
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    BRAND NEW OPENED BARD 4000MLL URINE DRAINAGE BAG WAS CONTAMINATED UPON OPENING. REF #(B)(4), LOT # NGKU1451, EXP. 2030-06-30. THE DRAINAGE BAG WAS NOT USED FOR PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554099 BARD® URINARY DRAINAGE BAG COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER KNX C. R. BARD, INC. 153509 NGKU1451 801741029608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown