BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 7024434 · Received November 13, 2017

    Report

    Report Number
    MW5073240
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 30, 2017
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    EZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A BARD INDWELLING URINARY CATHETER TUBING WAS CAUGHT BY THE PT'S LEGS DURING AN EPISODE OF CONFUSION RESULTING IN MECHANICALLY PULLING THE CATHETER PARTIALLY OUT. THE INFLATED CATHETER BALLOON BECAME LODGED IN THE MOST DISTAL PORTION OF THE MALE PT'S URETHRA WITHOUT EXITING THE PT'S BODY. AT UNSUCCESSFUL ATTEMPT WAS MADE BY THE RN TO DEFLATE THE CATHETER BALLOON BY ASPIRATION WITH A SYRINGE AT THE BALLOON PORT. THIS WAS FOLLOWED BY A CUT TO THE BALLOON PORT. CUTTING THE BALLOON PORT DID NOT SUCCESSFULLY DEFLATE THE BALLOON. SUCCESSFUL PASSIVE DECOMPRESSION OF THE BALLOON OCCURRED WHEN THE PROVIDER INSERTING A NEEDLE TO PUNCTURE THE BALLOON THROUGH THE URETHRAL OPENING. NO LASTING HARM WAS IDENTIFIED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806123 BARD 16FR FOLEY CATH EZL BARD MEDICAL DIVISION I. C. COMPLETE CARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention