BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070 ADVANCED

    MDR report key: 2625595 · Received October 27, 2009

    Report

    Report Number
    3005168196-2009-00081
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Date of Event
    September 25, 2009
    Report Date
    September 25, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: DURING THE DECONTAMINATION OF THE NEURON HUB WITH A BLEACH FLUSH, A LARGE CRACK IN THE HUB WAS NOTED WHICH LEAKED SIGNIFICANTLY. THE INCIDENT IS CONFIRMED AS REPORTED. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED. COMPLAINT/INCIDENT FINDINGS: A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS COMPLETED ON PART # 2314-04 (LOT # L15401). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    A CRACK IN THE HUB OF THE DEVICE WAS DISCOVERED WHEN THE PACKAGE WAS OPENED. THE NEURON WAS NOT USED AND THE HOSPITAL WAS ABLE TO OPEN ANOTHER NEURON FOR USE. THE PROBLEMATIC DEVICE DID NOT LEAD TO ANY PT INJURY ACCORDING TO THE HOSPITAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 ADVANCED SUBCUTANEOUS CATHETER DQY PENUMBRA, INC. F15401

    Patients

    Seq Age Sex Outcome Treatment
    1