BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 GAUGE NYLON EPIDURAL CATHETER

    MDR report key: 2974262 · Received February 12, 2013

    Report

    Report Number
    2974262
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 14, 2012
    Manufacturer
    SMITH MEDICAL ASD, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    B)(6) MALE PT WAS TO UNDERGO A NEPHRECTOMY. DURING PLACEMENT OF EPIDURAL CATHETER FOR REGIONAL ANESTHESIA, THE EPIDURAL CATHETER WAS NOT TRENDING INTO THE EPIDURAL SPACE, THE CATHETER WAS REMOVED, HOWEVER, UPON REMOVING THE CATHETER, IT WAS NOTED THAT PART OF THE CATHETER SHEARED OFF AND ABOUT 3-4 CM REMAINED IN THE PT'S BACK. NO FURTHER INTERVENTION WAS TAKEN AT THAT TIME. REF MFR REPORT 2183502-2013-00023,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62243 21 GAUGE NYLON EPIDURAL CATHETER CAZ SMITH MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR