BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL PORT ACCESS SYSTEMS

    MDR report key: 25751 · Received January 19, 1995

    Report

    Report Number
    25751
    Event Type
    Injury
    Date Received
    January 19, 1995
    Date of Event
    October 17, 1994
    Report Date
    October 24, 1994
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SHEARING OF THE CATHETER AT THE LEVEL OF CLAVICLE AND FIRST RIB SEVEN MONTHS AFTER INSERTION. DISTAL PART OF CATHETER AND THE PORT ARE IN PLACE. THE PROXIMAL PART OF CATHETER WAS IN RIGHT ATRIUM AND INFERIOR VENA CAVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL PORT ACCESS SYSTEMS Implant PORTA CATH CATHETER LJT COOK PACEMAKER CORP. 9112 ED - 1149

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R