BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DESERET EPIDURAL

    MDR report key: 846331 · Received April 6, 2007

    Report

    Report Number
    846331
    Event Type
    Malfunction
    Date Received
    April 6, 2007
    Date of Event
    March 29, 2007
    Report Date
    April 6, 2007
    Manufacturer
    DESERET MEDICAL INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: CAUDAL EPIDURAL STEROID INJECTION WITH TEMPORARY CATHETER PLACEMENT AND EPIDUROGRAM. THE INITIAL SOFT FLEXIBLE CATHETER THAT CAME WITH THE EPIDURAL KIT WAS NOT ABLE TO PASS INSIDE THE EPIDURAL SPACE, THEREFORE THE PHYSICIAN REQUESTED A HARDER CATHETER. HE WAS GIVEN A DESERET RADIOPAQUE TEFLON EPIDURAL LUMBAR CAUDAL EPIDURAL CATHETER WITH STYLET AND BLUNT NEEDLE, 19-GAUGE, 36 INCHES. THE CATHETER WAS PLACED WITHOUT ANY RESISTANCE OR PROBLEM. BEFORE THE CATHETER WAS REMOVED, IT WAS CLEARED WITH 0.25% BUPIVACAINE. THREE MILLILITERS IN TOTAL WAS GIVEN. THE CATHETER AND NEEDLE WERE REMOVED AS ONE UNIT, AND PLACED ON A TABLE. THE PHYSICIAN LOOKED AT THE EPIDURAL CATHETER AND NOTICED THAT IT APPEARED TO BE DIFFERENT AT ITS TIP. HE EVALUATED IT CLOSELY, AND IT APPEARED AS THOUGH THE CATHETER HAD BROKEN. HE WAS UNSURE IF THE CATHETER BROKE OFF INSIDE THE PATIENT OR HAD BROKEN AFTER THE REMOVAL. THE PHYSICIAN OPENED A NEW PACKAGE AND TESTED IT TO THE SIZE OF THE CATHETER, AND THERE APPEARED THAT APPROXIMATELY 4 CM OF THE OLD CATHETER WAS MISSING. A SCOUT FILM WAS DONE AND THERE WAS NO SIGN OF THE RADIOPAQUE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESERET EPIDURAL KIT, CATHETER, EPIDURAL CAZ DESERET MEDICAL INC. * M5DH890

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR OTHER