BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER, 14F

    MDR report key: 4210068 · Received October 15, 2014

    Report

    Report Number
    1417592-2014-00094
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    June 9, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE TO TWO DAYS POST INSERTION, THE RN ATTEMPTED TO REMOVE THE FOLEY CATHETER AND THE BALLOON WOULD NOT FULLY DEFLATE. SHE WAS ABLE TO REMOVE 7ML OF FLUID WITHOUT ISSUE BUT WAS UNABLE TO REMOVE THE REMAINING 2-3ML. THE CATHETER WAS PULLED OUT WITH A PARTIALLY INFLATED BALLOON INTACT. THE FACILITY REPORTED THAT NO SERIOUS INJURY RESULTED AND NO MEDICAL INTERVENTION WAS INITIATED AS A RESULT OF THIS INCIDENT. THE CATHETER WAS NOT REPLACED. THE SAMPLE WAS NOT RETURNED FOR EVAL. A ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE RN WAS UNABLE TO REMOVE APPROX 3ML OF FLUID FROM THE CATHETER'S BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656312 LATEX FOLEY CATHETER, 14F NWR MEDLINE INDUSTRIES, INC. 14CB9965

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other