BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCA INTRODUCER

    MDR report key: 458028 · Received May 2, 2003

    Report

    Report Number
    1316297-2003-00002
    Event Type
    Other
    Date Received
    May 2, 2003
    Date of Event
    April 29, 2003
    Report Date
    May 2, 2003
    Manufacturer
    EPIMED INTERNATIONAL
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR HAS COMPLETED LYSIS PROCEDURE AND ENCOUNTERED RESISTANCE WHEN ATTEMPTING TO REMOVE THE DEVICE. THEN REINSERTED INTRODUCER NEEDLE AND APPLIED STEADY PRESSURE TO THE NEEDLE/INTRODUCER COMBINATION. THE INTRODUCER STRETCHED AND EVENTUALLY SNAPPED. DR. THEN MADE A SMALL INCISION AND MADE ANOTHER ATTEMPT TO REMOVE INTRODUCER, BUT WAS UNSUCCESSFUL. PIECE OF INTRODUCER TIP REMAINED IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCA INTRODUCER EPIDURAL NEEDLE BSP EPIMED INTERNATIONAL 135-4940 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other EPIDURAL CATHETER.