BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX I.C. COMPLETE CARE

    MDR report key: 2517359 · Received March 23, 2012

    Report

    Report Number
    2517359
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 22, 2012
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS PREPPED FOR FOLEY CATHETER INSERTION. THE BALLOON WAS TESTED BY THE NURSE BY INJECTING AIR INTO IT AND NO DEFECTS WERE NOTED. THE CATHETER WAS INSERTED IN THE PT. AS THE NURSE WAS FILLING THE BALLOON WITH SALINE, SHE HEARD A STRANGE NOISE AND THE CATHETER CAME OUT WHEN TENSION WAS APPLIED. THE BREAK IN THE BALLOON WAS VISIBLE. THE NURSE STATED SHE HAD INJECTED BETWEEN EIGHT AND TEN ML OF SALINE INTO THE BALLOON WHEN THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX I.C. COMPLETE CARE FOLEY CATHETER KOD BARD MEDICAL DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR NO OTHER THERAPIES