BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY A.V. FISTULA CANNULATION SET

    MDR report key: 420565 · Received September 30, 2002

    Report

    Report Number
    1423500-2002-01174
    Event Type
    Malfunction
    Date Received
    September 30, 2002
    Date of Event
    September 10, 2002
    Report Date
    September 10, 2002
    Manufacturer
    NIPRO (THAILAND) CORPORATION LTD.
    Product Code
    FIE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSING DIRECTOR (ND) REPORTS ONE INCIDENT OF A FISTULA NEEDLE LEAKING AT THE HUB. THE LEAK WAS LARGE ENOUGH TO CAUSE THE NURSE TO RECANNULATE THE PATIENT. TREATMENT WAS RESTARTED WITH A NEW NEEDLE WITHOUT INCIDENT. ND STATES THAT THERE IS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT. THE NEEDLE BROKE INTO 2 PIECES WHEN ND WAS RINSING IT WITH BLEACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY A.V. FISTULA CANNULATION SET FISTULA SET FIE NIPRO (THAILAND) CORPORATION LTD. 5M4480 02C21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN