BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED DIALYSIS CATHETER

    MDR report key: 3162453 · Received June 6, 2013

    Report

    Report Number
    3006260740-2013-00278
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 15, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    DETAILS OF INCIDENT/NATURE OF DEVICE DEFECT: PATIENT ATTENDED FOR DIALYSIS AND ON CONNECTION TO MACHINE NURSE NOTED BLOOD LEAKING FROM SECTION JUST ABOVE THE BIFURCATION. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NO REPORTED INJURY TO ANY OF THE PARTS INVOLVED. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL OR BY THE MANUFACTURER OR SUPPLIER): PATIENT WAS DISCONNECTED FROM THE MACHINE, LUMENS WERE FLUSHED WITH NACL 0.9% AND CUPPED OFF. TRANSFERRED TO TH WARD FOR LINE CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251457 IMPLANTED DIALYSIS CATHETER CATHETER, HENODIALYSIS, IMPLANTED MSD C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention