BEUDAMED
    FDA Adverse Event Death Summary report: N

    GESCO/BARD ACCESS

    MDR report key: 34776 · Received May 2, 1996

    Report

    Report Number
    34776
    Event Type
    Death
    Date Received
    May 2, 1996
    Date of Event
    April 22, 1996
    Report Date
    April 30, 1996
    Manufacturer
    GESCO, INT'L.
    Product Code
    FOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PLACEMENT, THE CATHETER PULLED APART LEAVING APPROX. 9 CMS IN THE INFANT'S UMBILICAL AREA. RETRIEVAL WAS NOT POSSIBLE, INFANT TRANSFERRED TO HOSP. FACILITY REPORTED PT'S DEATH THROUGH RISK MANAGEMENT/QUALITY OFFICE. EXTERNAL PART OF DEVICE SENT TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GESCO/BARD ACCESS CATHETER FOS GESCO, INT'L. 51BF0067

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DAY Death