BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CONVENIENCE KIT

    MDR report key: 1587015 · Received January 15, 2010

    Report

    Report Number
    1721504-2010-00011
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 1, 2009
    Report Date
    December 16, 2009
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WAS RETURNED FOR EVAL. THE DEVICE WAS EXAMINED VISUALLY AND THE COMPLAINT WAS CONFIRMED. THE ROTATOR WAS SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MFG BONDING PROCESS. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. COMPLAINT DATA WILL BE MONITORED TO VERIFY EFFECTIVENESS OF CORRECTIVE ACTIONS TAKEN. DEVICE HISTORY RECORD WAS REVIEWED; COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR ON THE HPF200E TUBING WITH THE K10-04448 KIT CAME APART AT 690 PSI DURING CONTRAST INJECTION FOR AN ANGIOGRAM PROCEDURE. CUSTOMER ALSO INDICATED THE ROTATOR CAME APART AT 760 PSI BUT DID NOT INDICATE THERE WAS MORE THAN ONE EVENT. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CONVENIENCE KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. F703250

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA