BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL-PORT

    MDR report key: 153342 · Received January 29, 1998

    Report

    Report Number
    153342
    Event Type
    Malfunction
    Date Received
    January 29, 1998
    Report Date
    October 9, 1997
    Manufacturer
    VITAL-PORT VASCULAR ACCESS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PORT-A-CATH WORKING IMPROPERLY. INFILTRATING ON 09/25/1997 DURING OUTPATIENT CHEMO TREATMENT. PT SENT FOR X-RAY. CATHETER FOUND TO BE SHEARED OFF. BROKEN PIECE REMOVED ON 09/25/1997 DURING A PERCUTANEOUS RETRIEVAL OF CATHETER FRAGMENT. REST OF PORT SURGICALLY REMOVED ON 09/30/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL-PORT Implant PORT-A-CATH LJT VITAL-PORT VASCULAR ACCESS 9110 *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other