BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS SERIES STOPCOCK

    MDR report key: 2160124 · Received June 2, 2011

    Report

    Report Number
    1721504-2011-00192
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVAL. UPON VISUAL INSPECTION 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. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINT 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. THIS LOT WAS BUILT PRIOR TO IMPLEMENTATION OF THE NOTED CORRECTIVE ACTIONS. EVAL METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STOPCOCK ROTATORS ARE BREAKING DURING LEFT VENTRICULOGRAM AND ABDOMINAL AORTIC ANEURYSM STENTING PROCEDURES DURING INJECTION. THE INJECTION PRESSURE IS REDUCED DURING THE PROCEDURE, BUT THE ROTATORS ARE STILL FAILING AT APPROX 600 PSI. THE CUSTOMER REPORTED THAT THIS OCCURRED FIVE TIMES. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF FIVE REPORTS FOR THIS COMPLAINT: 1721504-2011-00193, 00194, 00195, 00196.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS SERIES STOPCOCK ADAPTOR, STOPCOCK, MANIFOLD, FITTING DTL MERIT MEDICAL SYSTEMS, INC. F719124

    Patients

    Seq Age Sex Outcome Treatment
    1