BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER KIT, 16F

    MDR report key: 3753394 · Received March 28, 2014

    Report

    Report Number
    1417592-2014-00037
    Event Type
    Injury
    Date Received
    March 28, 2014
    Date of Event
    December 14, 2013
    Report Date
    March 26, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RN HAD DIFFICULTY REMOVING THE CATHETER FOLLOWING A VAGINAL DELIVERY. THE PHYSICIAN PULLED ON THE CATHETER AND IT CAME OUT WITHOUT INJURY TO THE PATIENT. IT WAS NOTED THAT APPROXIMATELY 2ML OF FLUID REMAINED IN THE BALLOON. THE BALLOON WAS INTACT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. WE HAVE NOT CONFIRMED THE ISSUE OR IDENTIFIED A ROOT CAUSE.

    Description of Event or Problem · 1

    THE RN HAD DIFFICULTY REMOVING THE FOLEY CATHETER AND FOUND THAT THE BALLOON HAD APPROXIMATELY 2ML OF FLUID REMAINING IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184973 LATEX FOLEY CATHETER KIT, 16F NWR MEDLINE INDUSTRIES, INC. 13UB0208

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other