BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIPPER PLUS NEEDLE

    MDR report key: 2083353 · Received April 21, 2011

    Report

    Report Number
    2183502-2011-00182
    Event Type
    Injury
    Date Received
    April 21, 2011
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FPA
    PMA / PMN Number
    K040899
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: CUSTOMER REPORTED A NEEDLESTICK INJURY. THEY ALLEGE THAT THE EVENT WAS DUE TO THE NEEDLE NOT LOCKING INTO THE SAFETY POSITION. ONE USED INFUSION SET WAS RETURNED FOR EVAL. UPON EXAMINATION, NO ABNORMALITIES OR DEFECTS WERE FOUND. CRITICAL DIMENSIONS WERE FOUND TO CONFORM TO THE MFRS SPECIFICATIONS. VISUAL EXAMINATION REVEALED THAT THE SAFETY ARM WAS IN THE DOWN POSITION WITH THE NEEDLE FULLY EXTENDED, AND THE TIP EXPOSED. THE NEEDLE WAS RETRACTED PER THE IFU. IT CLICKED INTO PLACE NORMALLY, GIVING BOTH AN AUDIBLE AND TACTILE INDICATION OF LOCK-UP. UNABLE TO CONFIRM CUSTOMERS COMPLAINT.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIPPER PLUS NEEDLE FPA - SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL MD 21-2767 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1