BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1930451 · Received November 18, 2010

    Report

    Report Number
    1125782-2010-00005
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 11, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE WILL NOT BE RETURNED FOR EVAL/INVESTIGATION. ROOT CAUSE IS UNDER INVESTIGATION. MERIT DETERMINED ON (B)(4) 2010 THAT A PRODUCT CORRECTION WOULD BE REQUIRED FOR THE MERIT VALVED ONE-STEP CENTESIS DRAINAGE CATHETERS. CUSTOMERS ARE ADVISED TO DISCARD THE DEVICE AT THE POINT OF USE. THIS IS A 5-DAY MDR REPORT IN ACCORDANCE WITH STATUTORY REPORTING REQUIREMENTS. COMMUNICATIONS TO CONSIGNEES BEGAN ON (B)(4) 2010. A REPORT TO THE FDA IN ACCORDANCE WITH 21 CFR 806.10 IS ALSO IN PROCESS AND WILL BE SENT ON (B)(4) 2010. NO ADD'L FORM 3500A REPORTS WILL BE FILED FOR THIS EVENT. NOTIFICATION OF PRODUCT CORRECTION.

    Description of Event or Problem · 1

    THERE WERE TWO CASES IN WHICH THE HUB OF THE VALVED ONE-STEP LEAKED WHILE TRYING TO FLUSH THE CATHETER DURING PREP. THIS HAPPENED ANOTHER TIME AND THEY COULD NOT GET ANY FLUID AT ALL. NO LOT NUMBER REPORTED. NO DEVICES WILL BE RETURNED. NO REPORT OF HARM OR INJURY. THE CUSTOMER DID NOT PROVIDE ANY ADD'L INFO OR CLINICAL DETAILS FOR THE ADD'L EVENTS. THE CUSTOMER REPORTED 3 DEFECTIVE DEVICES BUT IS NOT EXPECTED TO RETURN ANY DEVICES. THIS IS ONE OF THREE REPORTS FOR THIS COMPLAINT: 1125782-2010-00003, 1125782-2010-00004.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1