BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC TITANIUM

    MDR report key: 477225 · Received August 1, 2003

    Report

    Report Number
    MW1029223
    Event Type
    Malfunction
    Date Received
    August 1, 2003
    Date of Event
    July 17, 2003
    Report Date
    August 1, 2003
    Manufacturer
    DELTEC
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PEEL-AWAY SHEATH BROKE LEAVING 6CM OF SHEATH ON THE PORT CATHETER BEING PLACED. NO MEDICAL RISK TO THE PT - SO PEEL-AWAY SHEET WAS LEFT ON THE PORT CATHETER. PORT POCKET WAS SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTEC TITANIUM PORT CATHETER LJT DELTEC M21198 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other