BEUDAMED
    FDA Adverse Event Death Summary report: N

    PER-Q-CATH PLUS

    MDR report key: 374519 · Received January 19, 2002

    Report

    Report Number
    374519
    Event Type
    Death
    Date Received
    January 19, 2002
    Date of Event
    December 29, 2001
    Report Date
    January 9, 2002
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PICC LINE WAS INSERTED VIA RIGHT ANTECUBITAL FOSSA AND LOCATION WAS CONFIRMED BY X-RAY. APPROX 3 HOURS LATER, WHEN 10CC OF TPN HAD BEEN ADMINISTERED, THE PT ARRESTED AND COULD NOT BE RESUSCITATED. AUTOPSY SHOWED PERICARDIAL TAMPONADE WITH LIKELY PERFORATION SITE BY THE PICC INTO THE ANTERIOR RIGHT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PER-Q-CATH PLUS PERIPHERALLY INSERTED CENTRAL CATHETER DQO BARD ACCESS SYSTEMS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY Death