BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEM

    MDR report key: 37191 · Received September 6, 1996

    Report

    Report Number
    37191
    Event Type
    Injury
    Date Received
    September 6, 1996
    Date of Event
    August 2, 1996
    Report Date
    August 6, 1996
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS HAVING A ROUTINE CXR AS PART OF HER FOLLOWUP FOLLOWING CHEMOTHERAPY. DURING THE X-RAY THE RADIOLOGIST NOTED THAT THE PORT-A-CATH CATHETER WAS SEPARATED FROM THE PORT. THE PT WAS BROUGHT TO THE SPECIAL PROCEDURES DEPT FOR RETRIEVAL OF THE PORTION OF THE CATHETER. THE PORT WILL BE EXPLANTED AT A LATER DATE. THE PT WAS NOT AWARE OF A PROBLEM AND THE PORT WAS NOT BEING USED FOR CHEMOTHERAPY AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEM Implant PORT-A-CATH CATHETER DQO BARD ACCESS SYSTEMS, INC. * 36JF0943

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization