BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECOMPRESSION CATHETER, 8-PIN

    MDR report key: 908697 · Received September 7, 2007

    Report

    Report Number
    1216828-2007-00041
    Event Type
    Malfunction
    Date Received
    September 7, 2007
    Date of Event
    July 26, 2007
    Report Date
    August 30, 2007
    Manufacturer
    SMITH & NEPHEW INC.- ENDOSCOPY DIVISION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED IN THE ANDOVER FACILITY ON 8/24/2007, HOWEVER, THE PRODUCT WAS NOT STERILIZED. PRODUCT IS BEING SHIPPED TO OKC FOR PROCESSING AND STERILIZATION. WHEN THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FORWARDED.

    Description of Event or Problem · 1

    DURING A DISC DECOMPRESSION PROCEDURE, THE DOCTOR ATTEMPTED TO REMOVE AND RELOCATE THE CATHETER INTO THE PT'S DISC AND THEN THE CATHETER BROKE. THE BROKEN PIECE OF THE CATHETER WAS LEFT INSIDE THE DISC. THE DOCTOR DOES NOT PLAN TO REMOVE THE PIECE OF THE CATHETER. THERE WAS NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DECOMPRESSION CATHETER, 8-PIN CATHETER, RF GEI SMITH & NEPHEW INC.- ENDOSCOPY DIVISION 7210442

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR