BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIMED EPIDURAL CATHETER

    MDR report key: 21731528 · Received March 31, 2025

    Report

    Report Number
    MW5168419
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    March 14, 2025
    Report Date
    March 26, 2025
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE REMOVING THE EPIDURAL CATHETER IN THE PHYSICIAN OFFICE, CATHETER BROKE AT THE SKIN SITE, LEAVING A REMNANT BEHIND. RETAINED LUMBAR CATHETER REQUIRED SURGICAL REMOVAL IN A HOSPITAL SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055477 EPIMED EPIDURAL CATHETER CATHETER, CONDUCTION, ANESTHETIC BSO EPIMED INTERNATIONAL, INC. 114213312

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization