BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070 ADVANCED

    MDR report key: 1545014 · Received November 12, 2009

    Report

    Report Number
    3005168196-2009-00101
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Date of Event
    November 2, 2009
    Report Date
    November 2, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS WAS AN OUT-OF-BOX FAILURE (MALFUNCTION NOTED UPON UNPACKING). THIS WAS DISPOSED OF AT THE HOSPITAL AND COULD NOT BE RETURNED FOR EVAL. AS PER FDA GUIDANCE ON 28 AUG 2009, KINKS (INCLUDING OUT-OF-BOX FAILURES) ARE REPORTABLE EVENTS. THE DHR OF THIS MFG LOT HAS BEEN REVIEWED AND COPY IS ATTACHED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 2314-04 (LOT # L15189). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. THE LOT HAS PASSED ALL DIMENSIONAL MEASUREMENTS PER SPEC. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPEC. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    UPON OPENING THE PACKAGING TO STOCK THE SHELF, THE PSC070 WAS FOUND TO BE CRUSHED IN THE MIDDLE. THE DAMAGED CATHETER WAS DISPOSED OF. BACK-UP CATHETERS WERE AVAILABLE AND THERE WERE NO DELAYS IN ANY CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 ADVANCED SUBCUTANEOUS CATHETER DQY PENUMBRA, INC. F15189

    Patients

    Seq Age Sex Outcome Treatment
    1