BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1963550 · Received December 20, 2010

    Report

    Report Number
    1721504-2010-00436
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 27, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVAL. 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 DEVICE WAS EXAMINED VISUALLY AND THE COMPLAINT WAS CONFIRMED. THE DEVICE HAS A MFG DEFECT. COMPLAINT DATA WILL BE MONITORED FOR THIS TYPE OF FAILURE. EVAL, METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED. RESULTS: QUALITY CONTROL.

    Description of Event or Problem · 1

    THE TUBING BURST NEAR THE MALE CONNECTOR DURING A LEFT VENTRICULOGRAM PROCEDURE AND SPRAYED. FLOW RATE- 10, VOLUME 30. 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. H111863

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA