BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 2112400 · Received May 31, 2011

    Report

    Report Number
    2112400
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 31, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    AC RN REPORTS LIDOCAINE WAS USED TO START A PATIENT IV. THE SAFETY DEVICE ACTIVATED ON A 27 GAUGE NEEDLE, THE CLICK WAS HEARD WHEN IT LOCKED INTO PLACE. RN WENT TO REMOVE THE NEEDLE AS LIDOCAINE IS NOT TO BE DISPOSED OF IN A SHARPS CONTAINER, THE SAFETY DEVICE FAILED AND A DIRTY NEEDLESTICK OCCURRED. STAFF MEMBER REPORTED TO OCCUPATIONAL HEALTH CLINIC FOR TREATMENT. UNFORTUNATELY, THE DEVICE WAS NOT RETAINED AND WAS DISPOSED OF. WHILE RESEARCHING EVENT, OTHER STAFF MEMBERS VERBALLY REPORTED HAVING THE SAME ISSUE HAPPEN, BUT DID NOT REPORT; HOWEVER, ONE HAD SAVED A DEVICE WITH WHICH THE SAME EXACT ISSUE OCCURRED. EDUCATED STAFF ON THE IMPORTANCE OF RETAINING FAILED DEVICES, ETC. ONE DEVICE IS AVAILABLE FOR EVALUTION PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO JELCO HYPODERMIC NEEDLE PRO EDGE SAFETY DEVICE FOZ SMITHS MEDICAL 402705 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *