BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD LUBRI-SIL

    MDR report key: 1891799 · Received October 29, 2010

    Report

    Report Number
    1891799
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 29, 2010
    Manufacturer
    C.R. BARD, INC
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN TRYING TO REMOVE A FOLEY CATHETER FROM A MALE PT, 4ML OF SALINE WAS REMOVED FROM THE BALLOON. NO ADDITIONAL SALINE WAS RETURNED, THE BALLOON DID NOT COMPLETELY DEFLATE, WHICH LEFT A RIDGE AND THE CATHETER WAS DIFFICULT TO REMOVE. A PEDIATRIC UROLOGIST WAS ABLE TO REMOVE THE CATHETER. THE PT WAS NOT HARMED. WE HAD ONE OTHER SIMILAR ISSUE SEVERAL MONTHS AGO, AND BELIEVE THAT THE PROBLEM LIES IN THE WAY THE BALLOON IS DEFLATED. THE INSTRUCTIONS INDICATE THE FLUID SHOULD NOT BE WITHDRAWN, BUT SHOULD DRAIN AND IN THAT INSTANCE AS WELL AS THIS ONE, WE SUSPECT THAT THE FLUID WAS WITHDRAWN, THEREBY LEAVING A SLIGHT RIDGE ON THE CATHETER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD LUBRI-SIL PEDIATRIC FOLEY CATHETER KOD C.R. BARD, INC 165810 *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR