BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA-KATH

    MDR report key: 11071867 · Received December 24, 2020

    Report

    Report Number
    11071867
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    September 18, 2020
    Report Date
    October 22, 2020
    Manufacturer
    EPIMED INTERNATIONAL, INC
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFANT MALE UNDERWENT SURGERY UNDER GENERAL ANESTHESIA. ANESTHESIOLOGIST HAD PLACED A CAUDAL EPIDURAL CATHETER FOR PAIN CONTROL ON DAY OF SURGERY. PER THE PHYSICIAN, STANDARD EPIDURAL REMOVAL - TEGADERM REMOVED FROM SKIN - IN CONTINUATION OF MOTION ¿ CATHETER WAS PULLED SMOOTHLY OUT WITHOUT ANY RESISTANCE. COMPLETED THE PROCEDURE 2 DAYS LATER AND PATIENT WAS DISCHARGED. PATIENT PRESENTED TO ER WITH EMESIS APPROXIMATELY 2 WEEKS LATER. IMAGING WAS OBTAINED THAT WAS NEGATIVE FOR OBSTRUCTION BUT INCIDENTALLY FOUND A RETAINED CATHETER FRAGMENT (10.4 CM) EXTENDING FROM THE LEVEL OF THE T9-T1- LEVEL TO THE L5-S1 LEVEL. THE DECISION WAS MADE BY PARENTS AND PROVIDERS TO REMOVE THE RETAINED EPIDURAL CATHETER FRAGMENT. LUMBAR LAMINECTOMY WITH FOREIGN BODY REMOVAL PERFORMED. DISCHARGED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535778 VERSA-KATH CATHETER, CONDUCTION, ANESTHETIC BSO EPIMED INTERNATIONAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 DA