BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRI PORT W/ATT O-E 12 FR. CATHETER

    MDR report key: 234789 · Received August 4, 1999

    Report

    Report Number
    1720496-1999-00232
    Event Type
    Death
    Date Received
    August 4, 1999
    Report Date
    June 18, 1999
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 12/22/98, DURING PLACEMENT OF PORT FOR CHEMO, A VEIN LACERATION OCCURRED WHICH DEVELOPED INTO A HEMOTHORAX. THE PATIENT EXPIRED; NUMEROUS ATTEMPTS WERE MADE TO STIMULATE THE HEART AND RESUSCITATE THE PATIENT, BUT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRI PORT W/ATT O-E 12 FR. CATHETER Implant INTRAVASCULAR IMPLANTED PORT LJT BARD ACCESS SYSTEMS 0603500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death