BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIPPER NEEDLE

    MDR report key: 3911566 · Received June 26, 2014

    Report

    Report Number
    2183502-2014-00447
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K870866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THIS DEVICE WAS IN USE WITH PATIENT FOR INFUSION OF MEDICATION. DURING INFUSION, THE USER FACILITY REPORTED THAT THE NEEDLE BECAME REMOVED FROM THE SEPTUM OF THE PORTAL AND CAUSED EXTRAVASATION IN THE PATIENT. THE USER FACILITY REPORTED TREATMENT WAS USED TO REMOVE THE PRODUCT INFUSED UNDER THE SKIN AND MEDICATION WAS APPLIED TO NEUTRALIZE IT. NO PERMANENT ADVERSE EFFECT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373025 GRIPPER NEEDLE FPA SMITHS MEDICAL MD, INC. 21-2947 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention