BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GANDRAS

    MDR report key: 1822286 · Received September 1, 2010

    Report

    Report Number
    2134812-2010-00027
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    June 25, 2010
    Report Date
    September 1, 2010
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K073200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DIFFERENT GANDRAS MODELS, 5581 AND 5582, ARE INCLUDED IN THIS REPORT. MANUFACTURER'S INVESTIGATION IS PENDING FINAL ROOT CAUSE DETERMINATION. SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONCLUSION OR ADMISSION BY VASCULAR SOLUTIONS, INC., THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE DEVICE FAILED OR MALFUNCTIONED IN ANY MANNER OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OF ANY PERSON.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT 1 BOX OF GANDRAS MODEL #5581 (4CM TIP) AND 1 BOX OF GANDRAS MODEL #5582 (6CM TIP) WERE EACH MISLABELED AS GANDRAS MODEL #5580 (2CM TIP). NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GANDRAS CATHETER DQO VASCULAR SOLUTIONS, INC. 5581 AND 5582 547954 AND 547955

    Patients

    Seq Age Sex Outcome Treatment
    1