BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 PRONG CYCLER SET

    MDR report key: 28548 · Received November 15, 1995

    Report

    Report Number
    2243621-1995-08013
    Event Type
    Injury
    Date Received
    November 15, 1995
    Date of Event
    November 10, 1995
    Report Date
    November 11, 1995
    Manufacturer
    FRESENIUS USA, INC.
    Product Code
    KPF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGED THAT THE ADAPTER ON THE 5 PRONG CYCLER SET DOES NOT FIT WELL ONTO THE PT'S CATHETER ADAPTER. IT IS DIFFICULT TO TIGHTEN INITIALLY AND THE PT ENDED UP CONTAMINATING HIS CATHETER AND DEVELOPING PERITONITIS. THE PT WAS PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 PRONG CYCLER SET 5 PRONG CYCLER SET KPF FRESENIUS USA, INC. 50-094-07

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention