BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

    MDR report key: 64546 · Received January 24, 1997

    Report

    Report Number
    MW1010598
    Event Type
    Death
    Date Received
    January 24, 1997
    Date of Event
    December 15, 1996
    Report Date
    January 15, 1997
    Manufacturer
    BARD ACCESS SYSTEMS, BARD VASCULAR ACCESS
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CRITICALLY ILL PREMATURE INFANT, POSSIBLE EXTRAVASATION OF PCVC INTO RIGHT PLEURAL SPACE ON DAY OF LIFE 5. CHEST TUBE WAS PLACE TO DRAIN PLEURAL EFFUSIION. INFANT CONTINUED TO DETERIORATE AND EXPIRED ON DAY OF LIFE 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER Implant PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER DQO BARD ACCESS SYSTEMS, BARD VASCULAR ACCESS * 51DG1020

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DAY Death| L