BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT MANIFOLDS

    MDR report key: 2192954 · Received July 21, 2011

    Report

    Report Number
    1721504-2011-00232
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION - THE EVALUATION HAS NOT BEEN COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD DID REVEAL ONE RELATED EXCEPTION DOCUMENT FOR LOT NUMBER F644004. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND ONE SIMILAR COMPLAINT FOR THE SAME LOT NUMBER. THE CUSTOMER WAS NOT SURE WHICH LOT THE SUSPECT DEVICE CAME FROM. THE CUSTOMER ALSO REPORTED THE FOLLOWING LOT NUMBERS: F644005, EXPIRATION DATE: 09/30/2011, DEVICE MANUFACTURE DATE: 10/2008; F725377, EXPIRATION DATE: 07/31/2012, DEVICE MANUFACTURE DATE: 07/2009; H190939, EXPIRATION DATE: 10/31/2013, DEVICE MANUFACTURE DATE: 12/2010; H200594, EXPIRATION DATE: 12/31/2013, DEVICE MANUFACTURE DATE: 01/2011; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. METHOD - DEVICE HISTORY RECORD WAS REVIEWED. COMPLAINT DATABASE WAS REVIEWED. CONCLUSION - A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ANGIOGRAPHIC PROCEDURE, THE ROTATOR ON THE MANIFOLD BROKE WHILE INJECTING CONTRAST. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT MANIFOLDS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. F644004

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA| TERUMO ANGIOGRAPHIC CATHETER