BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3901603 · Received May 7, 2014

    Report

    Report Number
    1721504-2014-00099
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IS THIS A SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT? UNKNOWN. THIS INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. DEVICE EVALUATION: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE OBSERVED. THE DEVICE WAS PRESSURE AND VACUUM TESTED AND NO LEAKS WERE OBSERVED. THE COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT AIR WAS ENTERING THE SYRINGE THROUGH THE MANIFOLD WHILE THE DEVICES WERE BEING PREPARED. SUBSEQUENT INFORMATION FROM THE ACCOUNT STATED THAT NO AIR WAS SEEN ENTERING FROM THE MANIFOLD. THE USER SUSPECTS THAT FLUID CAVITATION MAY EXPLAIN THE OBSERVED BUBBLES. THE DEVICE WAS EXCHANGES. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276071 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H558086

    Patients

    Seq Age Sex Outcome Treatment
    1