BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SAFETOUCH FISTULA NEEDLE

    MDR report key: 768644 · Received October 3, 2006

    Report

    Report Number
    2316883-2006-00001
    Event Type
    Malfunction
    Date Received
    October 3, 2006
    Date of Event
    May 17, 2006
    Report Date
    September 19, 2006
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FIE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CHIEF TECH CALLED TO REPORT THAT THEY HAD TWO INCIDENCES OF WHAT HE CALLED "PRODUCT FAILURE" INVOLVING THE NIPRO 14G X 1" SAFETOUCH FISTULA NEEDLE. WHEN CANNULATING A PATIENT, BLOOD BACKED UP INTO THE HUB AND LEAKED OUT. THEY PULLED OUT THE NEEDLE AND INSERTED ANOTHER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO SAFETOUCH FISTULA NEEDLE FISTULA NEEDLE 14G X 1" FIE NIPRO MEDICAL CORPORATION FS142530BC 04H11

    Patients

    Seq Age Sex Outcome Treatment
    1 *