BEUDAMED
    FDA Adverse Event Death Summary report: N

    GESCO/BARD ACCESS

    MDR report key: 86393 · Received April 17, 1997

    Report

    Report Number
    86393
    Event Type
    Death
    Date Received
    April 17, 1997
    Date of Event
    April 22, 1996
    Report Date
    April 30, 1996
    Manufacturer
    GESCO
    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 OF VAC, THE CATHETER PULLED APART LEAVING APPROX. 9 CMS IN THE INFANTS UMBILICAL ARTERY. RETRIEVAL WAS NOT POSSIBLE; INFANT TRANSFERRED. THAT FACILITY REPORTED PT'S DEATH THROUGH RISK MGMT/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 * 51GF0067

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DAY Death