BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER, 16F

    MDR report key: 3625098 · Received February 5, 2014

    Report

    Report Number
    1417592-2014-00009
    Event Type
    Injury
    Date Received
    February 5, 2014
    Date of Event
    December 20, 2013
    Report Date
    January 30, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A C-SECTION, THE FOLEY CATHETER FELL OUT. THE BALLOON WAS REPORTED TO BE DEFLATED BUT NOT RUPTURED. THE ENTIRE CATHETER WAS INTACT. A NEW CATHETER WAS INSERTED AND NO ADDITIONAL INTERVENTION WAS INDICATED. THE SAMPLE WAS NOT RETURNED FOR EVAL. NO LOT NUMBER PROVIDED. WE HAVE NOT CONFIRMED THE ISSUE OR IDENTIFIED A ROOT CAUSE. IN THE ABSENCE OF A BALLOON RUPTURE, IT IS POSSIBLE THE CATHETER BALLOON MAY NOT HAVE BEEN SUFFICIENTLY INFLATED AFTER IT WAS FIRST INSERTED INTO THE PT'S BLADDER.

    Description of Event or Problem · 1

    DURING A C-SECTION, THE CATHETER FELL OUT AND WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75997 FOLEY CATHETER, 16F NWR MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other