BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 3013845 · Received March 20, 2013

    Report

    Report Number
    3005168196-2013-00104
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 18, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DEVICE DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    PHYSICIAN WAS PREPPING CATHETER AND OVERTIGHTENED THE HEMOSTATIC VALVE AND STRIPPED THE HUB. DEVICE WAS NEVER PLACED IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116827 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. F29046

    Patients

    Seq Age Sex Outcome Treatment
    1