BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 413469 · Received August 29, 2002

    Report

    Report Number
    413469
    Event Type
    Injury
    Date Received
    August 29, 2002
    Date of Event
    April 25, 2002
    Report Date
    August 28, 2002
    Manufacturer
    CR BARD, INC
    Product Code
    FFH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER INSERTED INTO PELVIS TO DRAIN BLADDER. WHEN IT CAME TIME TO REMOVE CATHETER RN AND MD UNABLE TO DO SO. SEEN BY UROLOGIST WHO TOOK PT TO SURGERY TO REMOVE CATHETER. SINGLE KNOT FOUND UPON SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD INFANT CATH KIT FFH CR BARD, INC 0035630 76CM0801

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention