BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERICARDIOCENTESIS PROCEDURE KIT

    MDR report key: 755452 · Received August 24, 2006

    Report

    Report Number
    1628221-2006-00019
    Event Type
    Injury
    Date Received
    August 24, 2006
    Date of Event
    June 16, 2006
    Report Date
    August 23, 2006
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DOR
    PMA / PMN Number
    851088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN IS ANTICIPATED. A FAILURE INVESTIGATION WILL BE CONDUCTED. ONCE ADDITIONAL INFORMATION IS AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP TO THIS REPORT AND FORWARDED TO THE AGENCY. NOTE: MERIT'S SALES REPRESENTATIVE IN FRANCE FAILED TO REPORT THIS EVENT PROMPTLY TO MERIT'S RETURNED GOODS AUTHORIZATION DEPARTMENT, RESULTING IN A DELAY IN FILING THIS REPORT.

    Description of Event or Problem · 1

    DURING A PERICARDIOCENTESIS PROCEDURE PERFORMED IN A HOSPITAL, THE COMPLAINANT REPORTED THAT THE CLINICAN HAD DIFFICULTY REMOVING THE GUIDE WIRE FROM THE CATHETER. THE CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER, AND A NEW PERICARDIOCENTESIS CATHETER WAS PLACED IN THE PATIENT. THE EVENT DID NOT RESULT IN INJURY OR HARM TO THE PATIENT OR END USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERICARDIOCENTESIS PROCEDURE KIT PERICARDIOCENTESIS KIT W/PIGTAIL CATHE DOR MERIT MEDICAL SYSTEMS, INC. NA F421264

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening 6F DILATOR| PERICARDIOCENTESIS PIGTAIL CATHETER| 2 EACH 18 GAUGE AND 1 AND 19 GAUGE NEEDLES