BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPIDURAL CATHETERIZATION WITH FLEX TIP WITH CATHETER

    MDR report key: 562944 · Received December 28, 2004

    Report

    Report Number
    562944
    Event Type
    Other
    Date Received
    December 28, 2004
    Date of Event
    December 26, 2004
    Report Date
    December 27, 2004
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    BSO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IN LABOR AND HAD AN EPIDURAL ANESTHETIC. AFTER DELIVERY, THE EPIDURAL CATHETER WAS TO BE REMOVED. UPON REMOVAL, OF THE CATHETER BY THE CRNA, MUCH RESISTENCE WAS FELT. THE PT WAS REPOSITIONED & FURTHER ATTEMPT WAS MADE TO REMOVE WHICH WAS UNSUCCESSFUL. THE PT WAS REPOSITIONED AGAIN AND FURTHER ATTEMPT WAS MADE TO REMOVE WHICH WAS UNSUCCESSFUL. THE CRNA HELD CONTINUOUS TENSION AND FELT IT MOVE AND THEN IT SNAPPED OUT OF THE PT'S BACK. THE WIRE WAS HANGING OUT OF THE CATHETER AND THE TIP WAS MISSING. THE CRNA CLEANED THE SITE, APPLIED A BANDAID, INFORMED THE PT ON WHAT HAD HAPPENED AND NOTIFIED THE ATTENDING PHYSICIAN. ARRANGEMENTS WERE MADE WITH A NEUROLOGY GROUP TO CONTRACT PT THE DAY AFTER D/C FOR FURTHER CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION WITH FLEX TIP WITH CATHETER EPIDURAL CATHETERIZATION KIT 19 GUAGE BSO ARROW INTERNATIONAL UNK RF 4109728

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other