BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 054

    MDR report key: 2121867 · Received May 23, 2011

    Report

    Report Number
    3005168196-2011-00218
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    A HOLE WAS NOTED IN THE STERILE PACKAGING WHEN THE PENUMBRA SYSTEM REPERFUSION CATHETER 054 WAS OPENED. A NEW CATHETER 054 WAS USED WITHOUT ISSUE. THE PENUMBRA REPRESENTATIVE, WHILE SHIPPING THE CATHETER BACK FOR ANALYSIS, NOTED THAT THE CATHETER APPEARS TO HAVE BEEN USED WHICH DOES NOT AGREE WITH THE REPORTED COMPLAINT. AN INVESTIGATION WILL BE CONDUCTED AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 054 NRY PENUMBRA, INC. F19303

    Patients

    Seq Age Sex Outcome Treatment
    1