BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH BRAND ACCESS SYSTEMS

    MDR report key: 481435 · Received July 2, 2003

    Report

    Report Number
    481435
    Event Type
    Injury
    Date Received
    July 2, 2003
    Date of Event
    May 1, 2003
    Manufacturer
    DELTEC, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HAD PERITONEAL PORT-A-CATH PLACED IN 2002. IT BECAME NONFUNCTIONAL-OLD CATHETER AND POST REMOVED; NEW ONE INSERTED IN 2003. FRACTURE OCCURRED BETWEEN 2 SUTURED EDGES. BARD PORT INSERTED IN 2003 IN PERITONEUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH BRAND ACCESS SYSTEMS PERITONEAL VENOUS ACCESS LJT DELTEC, INC. 21-2000 68629

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention