BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER

    MDR report key: 3862974 · Received June 4, 2014

    Report

    Report Number
    1417592-2014-00057
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE PROVIDING PERI CARE TO A PT, THE FOLEY CAME OUT. THE BALLOON WAS NOT INFLATED AND THE CONTACT AT THE FACILITY COMMENTED THAT SHE DID NOT KNOW IF THE BALLOON HAD BEEN INFLATED WHEN THE CATHETER WAS INITIALLY INSERTED IN THE EMERGENCY ROOM. NO DAMAGE WAS NOTED TO THE CATHETER OR THE BALLOON. THEY ATTEMPTED TO INFLATE THE BALLOON AFTER IT FELL OUT BUT WERE NOT SUCCESSFUL. THE SAMPLE WAS NOT RETAINED FOR EVALUATION. WE HAVE NO ITEM NUMBER OR LOT NUMBER. NO PHOTOS WERE PROVIDED. THEY REPLACED THE CATHETER AND REPORTED THAT NO PT INJURY RESULTED FROM THIS INCIDENT. WE HAVE NOT IDENTIFIED A ROOT CAUSE. HOWEVER, IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    WHILE PERFORMING PERI-CARE, THE CATHETER FELL OUT AND WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326121 FOLEY CATHETER NWR MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other