BEUDAMED
    FDA Adverse Event Other Summary report: N

    NIPRO ARTERIAL VENOUS FISTULA NEEDLE

    MDR report key: 2700437 · Received March 15, 2006

    Report

    Report Number
    1056186-2006-00003
    Event Type
    Other
    Date Received
    March 15, 2006
    Date of Event
    February 3, 2006
    Report Date
    February 21, 2006
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE DID NOT APPEAR TO BE A PROBLEM WITH THE AVF NEEDLE INVOLVED IN THE INCIDENT THUS IT WAS DISCARDED BY THE USER FACILITY, AND COULD NOT BE DIRECTLY EVALUATED. THE MFR HAS REVIEWED THE DEVICE HISTORY RECORD FOR THIS LOT AND NO ABNORMALITIES WERE FOUND. NIPRO PRODUCT SPECIALIST INTERVIEWED THE NURSE MGR AT THE REPORTING FACILITY WHO STATED THAT SHE BELIEVED THE INCIDENT WAS DUE TO USE ERROR AND NOT A PRODUCT PROBLEM.

    Description of Event or Problem · 1

    EMPLOYEE OF CLINIC WAS PLACING AVF NEEDLE AFTER PT USE INTO THE SHARP CONTAINER WHEN NEEDLE FLIPPED BACK OUT OF OPENING AND NICKED BACK SIDE OF EMPLOYEE LEFT HAND.

    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 15GX1" HC-30W 05I23 B2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other