BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLINOIS (TJ) NEEDLE, ASPIRATION, 18G

    MDR report key: 1822046 · Received April 5, 2010

    Report

    Report Number
    1625685-2010-00011
    Event Type
    Injury
    Date Received
    April 5, 2010
    Date of Event
    February 23, 2010
    Report Date
    April 1, 2010
    Manufacturer
    CAREFUSION
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT SAMPLE WAS PROVIDED FOR EVAL, THEREFORE, WE WERE UNABLE TO DETERMINE THE EXACT CAUSE FOR THE ISSUE REPORTED. AN EVAL OF A CURRENT TIN3018 NEEDLE ASSEMBLY DID NOT IDENTIFY ANY SYSTEMATIC DESIGN ISSUES THAT MAY PROVIDE A HIGHER PROBABILITY OF OCCURRENCE OF THE STATED FAILURE MODE. A REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY PREVIOUS COMPLAINTS OF A SIMILAR NATURE. A REVIEW OF APPLICABLE MFG PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS MORE ABOUT THE DESIGN FEATURES OF THE PRODUCT. A NEW USER WAS STABBED IN THE HAND BY THE INTERNAL STYLET BECAUSE WHEN IT WAS REMOVED FROM THE CANNULA, AND PLACED ON THE TRAY IT DID NOT LAY FLAT (HORIZONTAL), BUT INSTEAD BALANCED ON THE BLUE T-HANDLE END, LEAVING THE STYLET VERTICAL, AND IN THE AIR. IT IS THOUGHT THAT THE BLUE END OF THE STYLET WHEN REMOVED FROM THE CANNULAR IS TOO HEAVY, AND NOT CONCAVE ENOUGH, SO IT SOMETIMES ENDS UP BALANCING ON THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLINOIS (TJ) NEEDLE, ASPIRATION, 18G ILLINOIS (TJ) NEEDLE, ASPIRATION, 18G KNW CAREFUSION TIN3018 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other