BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH MEDICAL

    MDR report key: 1141637 · Received August 28, 2008

    Report

    Report Number
    MW5008118
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    SMITH MEDICAL
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SMITH MEDICAL PORTEX CONTINUOUS EPIDURAL CATHETER INSERTED IN PT IN 2008. ON THE NEXT DAY AT 0950, CATHETER BROKE INTO. EPIDURAL CATHETER CLAMPED AND INFUSION STOPPED, MD NOTIFIED. SITE AND DRESSING CLEAN/DRY/INTACT WITH NO NOTED EVIDENCE OF DISLODGEMENT. EPIDURAL REMOVED BY MD, UPON INSPECTION OF CATHETER NOTED SECTION WHERE CATHETER BROKE HAD FLATTEN AREA APPROX 3 INCHES IN LENGTH WITH BREAK WITHIN THIS SECTION. THE ENDS OF EACH BREAK WERE STRAIGHT EDGE NOT JAGGED. CATHETER WAS BAGGED AND TAKEN TO MATERIALS MGMT. SMITH MEDICAL WERE NOTIFIED BY DIRECTOR OF MATERIALS MGMT. DATE OF USE: 2008 - 24 HOURS. DIAGNOSIS OR REASON FOR USE: EPIDURAL FOR NARCOTIC INFUSION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH MEDICAL PORTEX CONTINOUS EPIDURAL CAZ SMITH MEDICAL 8024-20 8024-20

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Disability