BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEL¿ MULTO-PURPOSE DRAINAGE CATHETER

    MDR report key: 6893949 · Received September 26, 2017

    Report

    Report Number
    6893949
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    August 3, 2017
    Report Date
    August 31, 2017
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT RETURNED TO HOSPITAL FOR DRESSING CHANGE DUE TO LEAKING ABSCESS DRAIN PLACED IN IR CT. THE TUBING AND STOPCOCK WERE NOT THE SOURCE OF THE LEAK. AFTER RT EVALUATED TUBE THE LEAK WAS FROM THE CATHETER HUB BEING CRACKED. PATIENT WAS KEPT AND PRE PROCEDURE WORK DONE IN SPEC PROCEDURE HOLDING AREA. DR. ORDERED FOR DRAINAGE CATHETER EXCHANGE AND TUBE WAS EXCHANGED UNDER X-RAY GUIDANCE. PATIENT WAS RECOVERED POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673386 EXPEL¿ MULTO-PURPOSE DRAINAGE CATHETER DRAINAGE CATHETER OEI BOSTON SCIENTIFIC CORPORATION 39311-105 20546327

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR