BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 553692 · Received October 14, 2004

    Report

    Report Number
    553692
    Event Type
    Other
    Date Received
    October 14, 2004
    Date of Event
    September 24, 2004
    Report Date
    October 14, 2004
    Manufacturer
    UNKNOWN AS LINE PLACED IN OUT OF STATE HOSPITAL
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH COMPLEX MEDICAL HISTORY INCLUDING MITOCHONDRIAL DISORDER, S/P, STATUS POST, LADDS PROCEDURE ABOUT TWO YEARS AGO, S/P NISSEN, STATUS POST GASTRODUODENAL BYPASS ABOUT A YEAR AGO. PATIENT TPN DEPENDENT, HAS GJ-TUBE, HISTORY OF MULTIPLE INFECTIONS. RIGHT CHEST SINGLE LUMEN BROVIAC PLACED ABOUT A YEAR AGO AT AN OUT-OF-STATE HOSPITAL. PATIENT HAD PRESENTED TO ED, EMERGENCY DEPARTMENT, WITH "BROKEN BROVIAC" AND IT WAS REPAIRED. PATIENT ADMITTED SEVERAL MONTHS LATER WITH FEVER. A COUPLE DAYS LATER, UNABLE TO DRAW BLOOD FROM LINE. WHEN ATTEMPTED TO FLUSH WITH 10:1 HEPARIN, NOTED LEAKAGE NEAR INSERTION SITE. ASSESSMENT OF AREA REVEALED SMALL OPENING ON LINE. BROVIAC SUCESSFULLY REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SINGLE LUMEN BROVIAC CATHETER DQO UNKNOWN AS LINE PLACED IN OUT OF STATE HOSPITAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR OTHER| LONG-TERM ANTIBIOTICS