BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO BLOOD COLLECTION NEEDLE

    MDR report key: 1987121 · Received February 7, 2011

    Report

    Report Number
    1056186-2011-00001
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K992699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE HAS BEEN RETURNED FOR EVAL, HOWEVER, THE EVAL IS STILL ONGOING. EVAL RESULTS WILL BE REPORTED WHEN COMPLETE.

    Description of Event or Problem · 1

    THE CLINICIAN WAS DRAWING BLOOD WHEN THEY NOTICED A LEAK FROM THE BACK OF THE NEEDLE. WHEN NEEDLE PULLED OUT IT SPLASHED INTO THE FACE OF THE CLINICIAN. CLINICIAN WENT TO THE HOSPITAL WAS SEEN BY THE DOCTOR AND LATER DETERMINED THAT THE EXPOSURE WAS NOT A RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE FMI NIPRO MEDICAL CORPORATION NM+21G25 10E26

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization