BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT MANIFOLDS

    MDR report key: 2062356 · Received March 18, 2011

    Report

    Report Number
    1721504-2011-00109
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE OEM CUSTOMER REPORTED FIVE ADDITIONAL COMPLAINTS FROM THE PAST YEAR. THE FOLLOWING LOT NUMBERS CORRESPOND TO THE OTHER FIVE COMPLAINTS: (B)(4), EXPIRATION DATE: 07/31/2011, DEVICE MANUFACTURE DATE: 07/2008. (B)(4), EXPIRATION DATE: 08/31/2011, DEVICE MANUFACTURE DATE: 08/2008. (B)(4), EXPIRATION DATE: 10/31/2011, DEVICE MANUFACTURE DATE: 10/2008. (B)(4), EXPIRATION DATE: 02/28/2012, DEVICE MANUFACTURE DATE: 03/2009. (B)(4), EXPIRATION DATE: 04/30/2012, DEVICE MANUFACTURE DATE: 04/2009. CONCLUSION: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING USE. NO FURTHER INFORMATION IS AVAILABLE. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED TWO DEFECTIVE DEVICES BUT DID NOT PROVIDE ANY FURTHER INFORMATION OR CLINICAL DETAILS FOR THE ADDITIONAL EVENT. THEREFORE, THIS SINGLE FORM FDA 3500A WILL BE SUBMITTED FOR THIS COMPLAINT. THE OEM CUSTOMER ALSO REPORTED FIVE ADDITIONAL COMPLAINTS FROM THE PAST YEAR FOR THE SAME FAILURE MODE. THIS IS ONE OF SIX TOTAL REPORTS: 1721504-2011-00107, 1721504-2011-00108, 1721504-2011-00110, 1721504-2011-00111, 1721504-2011-00112.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT MANIFOLDS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. F693270

    Patients

    Seq Age Sex Outcome Treatment
    1