BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER, 14F

    MDR report key: 4173273 · Received September 27, 2014

    Report

    Report Number
    1417592-2014-00087
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 24, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE ATTEMPTING TO REMOVE THE CATHETER FROM A LABOR AND DELIVERY PT, THE BALLOON WOULD NOT DEFLATE. A NEEDLE WAS INSERTED SUPRAPUBICALLY WITH THE AID OF ULTRASOUND TO MANUALLY RUPTURE THE BALLOON. THE SAMPLE WAS RETURNED TO US IN SIX PIECES. EACH PIECE/SECTION OF THE CATHETER WAS TESTED WITH AIR AND WATER FOR CONTINUOUS FLOW. ALL PARTS OF THE CATHETER ALLOWED FOR A FREE FLOW WITHOUT ANY OBSTRUCTION. THE FOLEY BALLOON INFLATED AND DEFLATED WITHOUT ANY ISSUES. THE INFLATION EYE WAS VISUALLY INSPECTED. THERE WAS NO INDICATION THAT WOULD SUGGEST AN OBSTRUCTION IN THE EYE. THERE WAS A LARGE OPENING IN THE EYE THAT ALLOWED FOR WATER TO FLOW PASSIVELY THROUGH THE INFLATION LUMEN. BECAUSE EACH PIECE EXHIBITED CONTINUOUS FLOW, A FAILURE INDICATING A NON-DEFLATING BALLOON WAS NOT IDENTIFIED. A ROOT CAUSE FOR THE REPORTED INCIDENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE BALLOON WOULD NOT DEFLATE AND WAS MANUALLY RUPTURED WITH A NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603681 LATEX FOLEY CATHETER, 14F NWR MEDLINE INDUSTRIES, INC. 14QB5250

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention