BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER KIT

    MDR report key: 23644319 · Received November 25, 2025

    Report

    Report Number
    23644319
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    September 5, 2025
    Report Date
    September 22, 2025
    Manufacturer
    C.R. BARD INC.
    Product Code
    FFH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CATH KIT HAS DEFECT WHERE THE CATHETER FALLS OUT OF THE COLLECTION CONTAINER DURING THE PROCEDURE. THIS HAS CAUSED URINE TO SPILL OUT OF THE CONTAINER MID-COLLECTION, IN ONE INSTANCE VIOLATED THE STERILE FIELD, AND HAS RESULTED IN US HAVING TO OPEN SEVERAL KITS FOR SOME PATIENTS. WE HAVE TWO SEPARATE EXAMPLES RIGHT NOW WITH TWO LOT NUMBERS: NGJW2398 AND NGJV1962.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2714658 CATHETER KIT COLLECTOR, URINE, PEDIATRIC, FOR INDWELLING CATHETER FFH C.R. BARD INC. NGJW2398 AND NGJV1962

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Male