BEUDAMED
    FDA Adverse Event Other Summary report: N

    NIPRO ARTERIAL VENOUS FISTULA NEEDLE

    MDR report key: 3126515 · Received February 17, 2006

    Report

    Report Number
    1056186-2006-00001
    Event Type
    Other
    Date Received
    February 17, 2006
    Date of Event
    January 31, 2006
    Report Date
    February 7, 2006
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THERE DID NOT APPEAR TO BE A PROBLEM WITH THE AVF NEEDLE INVOLVED IN INCIDENT THUS IT WAS DISCARDED BY THE USER FACILITY, AND COULD NOT BE DIRECTLY EVALUATED. THE MFR ALSO REVIEWED THE DEVICE HISTORY RECORD FOR THIS LOT AND NO ABNORMALITIES WERE FOUND. NIPRO PRODUCT SPECIALIST INTERVIEWED THE NURSE MANAGER AT THE REPORTING FACILITY AND DISCOVERED THAT THE STAFF MEMBER INVOLVED IN THE INCIDENT WAS IN THE SECOND WEEK OF TRAINING AND THE INCIDENT IS BELIEVED TO BE RELATED TO LACK OF TRAINING AND EXPERIENCE. THE PT BEING TREATED HAD NEGATIVE RESULTS FOR BLOOD-BORNE PATHOGENS. ADDITIONAL TRAINING IS BEING SCHEDULED AT THE FACILITY.

    Description of Event or Problem · 1

    U/F REF #: (B)(4)-2006-0001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO ARTERIAL VENOUS FISTULA NEEDLE ARTERIAL VENOUS FISTULA NEEDLE FIE NIPRO MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other