BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER

    MDR report key: 10930059 · Received December 1, 2020

    Report

    Report Number
    1316297-2020-00002
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    September 18, 2020
    Report Date
    December 1, 2020
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD GENERAL ANESTHESIA FOR SURGICAL PROCEDURE ON (B)(6) 2020. WHILE THE PATIENT WAS UNDER ANESTHESIA, A CAUDAL EPIDURAL WAS PLACED FOR PAIN MANAGEMENT POST-OP. THE PATIENT HAD THE EPIDURAL REMOVED ON (B)(6) 2020. AT THE TIME OF THE REMOVAL, THE PROVIDER REMOVING THE CATHETER THOUGHT THE ENTIRE CATHETER WAS REMOVED. THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT FOR EMESIS AND IT WAS DISCOVERED THROUGH X-RAY THAT 10.4CM OF THE EPIDURAL CATHETER WAS RETAINED INSIDE THE PATIENT EPIDURAL SPACE. THE DECISION WAS MADE BY THE PARENTS AND PROVIDERS TO SURGICALLY REMOVE THE RETAINED EPIDURAL. THE PATIENT HAD A RIGHT L4-L5 HEMILAMINECTOMY TO REMOVE THE EPIDURAL FOREIGN BODY. AT THE TIME OF THE EVENT, THE PATIENT HAD NO PRIOR SIGNIFICANT MEDICAL HISTORY. THE PATIENT IS RECOVERING FROM BOTH SURGERIES AT THIS TIME, AND IS RECOVERING PER STANDARD EXPECTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390724 CATHETER VERSA-KATH BSO EPIMED INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Required Intervention