BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESIO CATHETER

    MDR report key: 347593 · Received August 17, 2001

    Report

    Report Number
    347593
    Event Type
    Injury
    Date Received
    August 17, 2001
    Date of Event
    July 20, 2001
    Report Date
    August 8, 2001
    Manufacturer
    MEDCOMP, QA
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO THE EMERGENCY ROOM FOR REMOVAL OF AN INFECTED TESIO CATHETER. THE PHYSICIAN WAS IN THE PROCESS OF REMOVING THE CATHETER WHEN IT BROKE. FLUOROSCOPIC ASSISTANCE WAS PROVIDED FOR REMOVAL OF THE LEFT SUBCLAVIAN TESIO CATHETER. THE PHYSICIAN SUBSEQUENTLY PERFORMED AN INCISION TO LOCATE AND REMOVE THE CATHETER WITHIN THE SUBCUTANEOUS SOFT TISSUE OF THE UPPER LEFT CHEST WALL. THE DEVICE WAS INADVERTENTLY DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37866 TESIO CATHETER LEFT SUBCLAVIAN CATHETER LFJ MEDCOMP, QA NA M039390

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention