BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT CUSTOMER KIT

    MDR report key: 2092806 · Received May 11, 2011

    Report

    Report Number
    1721504-2011-00156
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER. THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. THE ACTUAL DATE OF THE EVENT WAS REPORTED TO BE APPROXIMATELY ONE MONTH PRIOR TO THIS REPORT DATE. THE CUSTOMER COULD NOT CONFIRM THE EXACT DATE THAT THE EVENT OCCURRED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFO BECOMES AVAILABLE. EVAL METHOD: THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT HE FEELS THERE MAY HAVE BEEN A PROBLEM WITH THE MANIFOLD TO SYRINGE CONNECTION. THE SYRINGES TIGHTEN TOO MUCH. THE SYRINGE WAS BACKED OFF FROM THE MANIFOLD AND THIS ALLOWED FOR THE ASPIRATION OF AIR. AIR WAS INJECTED INTO A PT. NO HARM OR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening CORONARY CONTROL SYRINGE| MANIFOLD