BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1881820 · Received October 8, 2010

    Report

    Report Number
    1721504-2010-00315
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION/INVESTIGATION. THE CUSTOMER REPORTED, THREE (3) DIFFERENT POTENTIAL LOT NUMBERS FOR THE FAILED DEVICE. F756929, EXPIRATION DATE- 11/30/2012, MANUFACTURER DATE- 11/2009. F773726, EXPIRATION DATE- 01/31/2013, MANUFACTURE DATE- 1/2010. H101311, EXPIRATION DATE- 02/28/2013, MANUFACTURER DATE- 02/2010. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. H6. EVALUATION CODES: CONCLUSIONS: OTHER, A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING USE. LOT NUMBER OF BROKEN DEVICE IS UNKNOWN. NO HARM OR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA