BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER PLUS NEEDLE

    MDR report key: 1011914 · Received March 10, 2008

    Report

    Report Number
    2183502-2008-00042
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 13, 2008
    Report Date
    March 7, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR COMPLETED THE ENTIRE FORM. ADD'L MFR NARRATIVE: CUSTOMER REPORTED A NEEDLESTICK INJURY. THEY ALLEGE THAT THE EVENT WAS DUE TO THE NEEDLE NOT LOCKING INTO THE SAFETY POSITION. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. THE DEVICE WAS REPORTEDLY DISCARDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A NEEDLESTICK INJURY. THEY ALLEGE THAT THE EVENT WAS DUE TO THE NEEDLE NOT LOCKING INTO THE SAFETY POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIPPER PLUS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FMI SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 21-2868 221X37

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK