BEUDAMED
    FDA Adverse Event Other Summary report: N

    SINGLE PORT

    MDR report key: 512067 · Received February 18, 2004

    Report

    Report Number
    512067
    Event Type
    Other
    Date Received
    February 18, 2004
    Date of Event
    September 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    C.R. BARD, INC.
    Product Code
    LJT
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS WAS THE END OF CHEMOTHERAPY TREATMENT FOR THIS PT. THE DOCTOR NOTICED NOTICED A GROWTH AT THE END OF THE CATHETER. IT WAS SENT TO PATHOLOGY BUT THE RESULTS ARE UNK. THE PT MAY NOT HAVE RECEIVED THE APPROPRIATE DOSAGE OF CHEMO MEDICATION. THE CATHETER WAS RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/12/04: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER, THEREFORE MFR CAN NOT DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE PORT SINGLE PORT CATHETER LJT C.R. BARD, INC. 0602230 22IKA 410

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR