BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 11699 · Received February 23, 1994

    Report

    Report Number
    11699
    Event Type
    Injury
    Date Received
    February 23, 1994
    Date of Event
    December 8, 1993
    Report Date
    December 13, 1993
    Manufacturer
    C. R. BARD, INC.
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NUMEROUS PATIENTS DEVELOPED "LEAKING" AT ATHERI FOLEY CATHETER DEVICES. CONTACT WAS MADE WITH BARD UROLOGICAL DIVISION. FOLEY CATHETER LEAKING AT CONNECTION SITE. LEAKING UNDER PLASTIC LIP (ALSO NOTED HAIRLINE CRACK IN TUBING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD BARD URINARY DRAINAGE BAG SYSTEM EYZ C. R. BARD, INC. 154002 VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention