BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KITS

    MDR report key: 2961160 · Received January 30, 2013

    Report

    Report Number
    9616662-2013-00008
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS INC
    Product Code
    DQO
    PMA / PMN Number
    K913161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL. THE SUSPECTED DEVICE HAS NOT BEEN RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING AN ANGIOGRAPHIC PROCEDURE, THE FEMALE LUER OF THE MANIFOLD IN THE KIT CRACKED WHILE CONNECTED TO A SYRINGE. AIR BUBBLES WERE SEEN IN THE SYSTEM WHEN ASPIRATING CONTRAST. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41299 MERIT CUSTOM KITS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS INC K409898

    Patients

    Seq Age Sex Outcome Treatment
    1 SYRINGE| CONTRAST MEDIA