BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAFLEX EPIDUAL CATHETER

    MDR report key: 678271 · Received February 17, 2006

    Report

    Report Number
    678271
    Event Type
    Other
    Date Received
    February 17, 2006
    Date of Event
    January 5, 2006
    Report Date
    January 6, 2006
    Manufacturer
    PORTEX INC.
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TERM PREGNANCY. EPIDURAL CATHETER PLACED WITH 6" EPIDURAL NEEDLE, (+) LOR, FLUID/BLOOD, SOFT FLEXIBLE PORTEX EPIDURAL CATHETER THREADED EASILY. BECAUSE OF PATIENT'S SIZE AND DEPTH, TEST DOSE WAS ATTEMPTED, BUT UNABLE TO INJECT. BEGAN TO REMOVE CATHETER, WHICH APPEARED TO BE STUCK AND FRAYED. REPOSITIONED CATHETER, INJECTED PFNS EASILY TO EXPAND THE SPACE. CATHETER STILL APPEARED TO BE STUCK, SO REMOVED BOTH THE NEEDLE AND CATHETER, WHICH LEFT THE SMALL UNCOILED WIRE IN THE PATIENT'S BACK. UNCOILED WIRE WAS REMOVED SLOWLY, WHICH EVENTUALLY CAME OUT. UNDETERMINED IF ANY RETAINED PIECE.(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAFLEX EPIDUAL CATHETER CATHETER BSO PORTEX INC. REF 4917M-19 K518686 (USE BY 2009-03)

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other