BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRAY 45 PERMACATH

    MDR report key: 303622 · Received November 1, 2000

    Report

    Report Number
    3032312-2000-00008
    Event Type
    Other
    Date Received
    November 1, 2000
    Date of Event
    August 12, 2000
    Report Date
    October 31, 2000
    Manufacturer
    THE KENDALL COMPANY
    Product Code
    MPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    KHCP RECEIVES MEDWATCH #1019789 FROM FDA ON 10/23/2000 FOR A PERMACATH ARTERIAL PORT TUBING FOUND TO HAVE PINHEAD SIZED LEAK (EVERY MINUTE), BUT VISIBLE. THIS WAS DISCOVERED DURING HEMODIALYSIS TREATMENT BY THE CHARGE NURSE. OCCURRED AT DIALYSIS CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAY 45 PERMACATH PERMACATH MPB THE KENDALL COMPANY * 103715

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other