BEUDAMED
    FDA Adverse Event Summary report: N

    NIPRO BLOODLINE

    MDR report key: 919469 · Received October 25, 2006

    Report

    Report Number
    2316883-2006-00002
    Date Received
    October 25, 2006
    Date of Event
    October 19, 2006
    Report Date
    October 23, 2006
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FIB
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTERS REPORTED THAT SOME OF THE NIPRO BLOOD LINES THAT THEY HAD RECEIVED HAD A KINK IN THE TUBING. INITIALLY, THE PROBLEM WAS THOUGHT TO BE COSMETIC IN NATURE WITH NO EFFECT ON PERFORMANCE. FURTHER COMPLAINTS WERE MADE THAT THE KINK "INHIBITS PROPER FLOW AND CAUSES COMPLICATIONS DURING DIALYSIS." THE VENOUS LINE OF AN UNUSED SET IS BEING HELD FOR PICKUP, AND RETURN TO NIPRO MEDICAL CORPORATION FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO BLOODLINE BLOOD TUBING SET FOR DIALYSIS FIB NIPRO MEDICAL CORPORATION A209/V803 06D05

    Patients

    Seq Age Sex Outcome Treatment
    1 *