BEUDAMED
    FDA Adverse Event Other Summary report: N

    NIPRO

    MDR report key: 627414 · Received August 15, 2005

    Report

    Report Number
    8041145-2005-00001
    Event Type
    Other
    Date Received
    August 15, 2005
    Date of Event
    June 17, 2005
    Report Date
    August 2, 2005
    Manufacturer
    NIPRO MEDICAL CORPORATION.
    Product Code
    FIB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT WAS RECEIVED IN 07/2005 THAT BLOOD TUBING LEAKED 50-75 CC BLOOD AT PUMP SEGMENT CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO DIALYSIS BLOOD LINES FIB NIPRO MEDICAL CORPORATION. A217/V806 04K29

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other