BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO

    MDR report key: 768656 · Received October 3, 2006

    Report

    Report Number
    2316883-2004-00001
    Event Type
    Malfunction
    Date Received
    October 3, 2006
    Date of Event
    August 11, 2004
    Report Date
    September 19, 2006
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT WHILE REMOVING THE SYRINGE FROM THE CATHETER PORT OF THE PT DURING A DIALYSIS TREATMENT, THE NURSES NOTICED THAT THE LUER LOCK HAD BROKEN OFF INSIDE THE PATIENT'S CATHETER. THE CUSTOMER FURTHER STATED THAT THE BROKEN PIECE OF THE SYRINGE HAD TO BE REMOVED FROM THE PATIENT'S CATHETER WITH HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO 10CC SYRINGE WITH NEEDLE FMF NIPRO MEDICAL CORPORATION JD10L *

    Patients

    Seq Age Sex Outcome Treatment
    1 *