BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    BARD URINE METER FOLEY CATHETER TRAY WITH BARDEX LUBRICATH FOLEY CATHETER

    MDR report key: 14976124 · Received July 11, 2022

    Report

    Report Number
    14976124
    Event Type
    No answer provided
    Date Received
    July 11, 2022
    Date of Event
    June 13, 2022
    Report Date
    June 28, 2022
    Manufacturer
    C. R. BARD, INC.
    Product Code
    EZC
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INDWELLING CATHETER PLACED AND UPON ATTEMPTING TO UNFOLD THE DRAINAGE BAG, IT WAS NOTED THAT THE BAG WAS ADHERED TO ITSELF, AND THE BAG SUBSEQUENTLY RIPPED OPEN MAKING IT NOT A CLOSED SYSTEM; BAG NEEDED TO BE REPLACED. PATIENT'S RN WAS TO REPLACE BAG AND SAVE DAMAGED BAG FOR REVIEW. MANUFACTURER RESPONSE FOR INDWELLING URINARY CATHETER, URINE METER FOLEY CATHETER TRAY, 14 FRENCH (PER SITE REPORTER). EMAILED BD REQUESTING ASSISTANCE. BARD REP WILL COORDINATE THE PRODUCT INVESTIGATION IF THE SAMPLE CAN BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058428 BARD URINE METER FOLEY CATHETER TRAY WITH BARDEX LUBRICATH FOLEY CATHETER CATHETER, COUDE EZC C. R. BARD, INC. 902914 NGEY2121, NGGR1053

    Patients

    Seq Age Sex Outcome Treatment
    1 Female