BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT HEMOSTASIS VALVE

    MDR report key: 2236240 · Received August 25, 2011

    Report

    Report Number
    9616662-2011-00050
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQX
    PMA / PMN Number
    K042060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER. THE FOLLOWING LOT NUMBERS FOR THE SAME PRODUCT WERE EVALUATED. K264027, EXP DATE: 06/30/2014. DEVICE MFR DATE: 07/2011. K261103, EXP DATE: 06/30/2014. DEVICE MFR DATE: 07/2011. K254983, EXP DATE: 05/31/2014. DEVICE MFR DATE: 06/2011. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL: METHOD: DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AIR ENTERED THE SYSTEM RESULTING IN AN EMBOLISM. STANDARD PROCEDURE FOR TREATMENT OF EMBOLISM WAS PROVIDED TO THE PT. THE CUSTOMER REPORTED THREE DEFECTIVE DEVICES BUT DID NOT PROVIDE ANY FURTHER INFO OR CLINICAL DETAILS FOR THE ADD'L EVENTS. THEREFORE, THIS SINGLE FORM FDA 3500 A WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT HEMOSTASIS VALVE ADAPTOR, STOPCOCK, MANIFOLD, FITTING DQX MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening