BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1647764 · Received March 29, 2010

    Report

    Report Number
    3005168196-2010-00461
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Report Date
    March 14, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: DURING DECONTAMINATION, A LEAK WAS OBSERVED IN THE HUB OF THE CATHETER. CRACKS COULD BE SEEN IN THE BODY OF THE HUB AT THE LEAK POINT. THE INCIDENT WAS CONFIRMED AS REPORTED. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED AND A COPY OF THE REVIEW IS ATTACHED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART #2314-01, (LOT #L15503). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION. 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

    THE HOSPITAL CHECKED THE DEVICE BEFORE USE AND FOUND THAT THE "CONNECTOR HAVE A FISSURE" [THE HUB WAS CRACKED]. THE DEVICE WAS NEVER USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15503

    Patients

    Seq Age Sex Outcome Treatment
    1