BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUBRICATH

    MDR report key: 5935658 · Received September 8, 2016

    Report

    Report Number
    5935658
    Event Type
    Malfunction
    Date Received
    September 8, 2016
    Date of Event
    August 18, 2016
    Report Date
    August 26, 2016
    Manufacturer
    CR BARD
    Product Code
    NWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLEY CATHETER INSERTED PER ORDER, URINE IMMEDIATELY STARTING LEAKING FROM CONNECTION BETWEEN 16FR CATHETER AND BAG. LEAKING BAG REMOVED AND REPLACED BY ANOTHER BAG. ADDITIONALLY, L&D UNIT HAD THREE OTHER FOLEY TRAY KITS LEAK AT THE CATHETER INSERT. MANUFACTURER RESPONSE FOR URINARY CATHETER, (BRAND NOT PROVIDED) (PER SITE REPORTER): SUBMITTING THE ISSUE TO BARD FIELD ASSURANCE AND SOMEONE WILL BE IN TOUCH. RED-BAG, PRE-PAID SHIPPING LABEL AND RETURN BOX BEING SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587656 LUBRICATH CATHETER, URINARY, KIT NWR CR BARD

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR NO| NO OTHER THERAPIES