BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERICARDIOCENTESIS KIT

    MDR report key: 22288472 · Received June 18, 2025

    Report

    Report Number
    1721504-2025-00095
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 25, 2025
    Report Date
    June 18, 2025
    Manufacturer
    MERIT MEDICAL RICHMOND
    Product Code
    PXU
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT THE PATIENT UNDERWENT A PERICARDIOCENTESIS PROCEDURE. THE PROCEDURE WAS UNCOMPLICATED AND 500+MLS OF FLUID WAS REMOVED DURING THE PROCEDURE. THE PATIENT STATED THAT HER BREATHING WAS EASIER AND AN ECHO DEMONSTRATED A REDUCTION IN THE SIZE OF THE PERICARDIAL EFFUSION. A DRAINAGE BAG WAS LEFT CONNECTED TO THE DRAIN TO ALLOW RESIDUAL FLUID TO BE COLLECTED. THE PATIENT RETURNED TO ACCUHC VIA THE X-RAY DEPARTMENT, WHERE A POST PROCEDURE CHEST X-RAY WAS PERFORMED. THE CXR WAS REPORTED AND SHOWED A MODERATE VOLUME PNEUMOPERICARDIUM. THE AIR WAS REMOVED FROM THE PERICARDIUM VIA THE DRAIN. A FOLLOWUP ECHO DEMONSTRATED RESOLUTION OF PERICARDIAL EFFUSION BUT SHOWED THE PATIENT DEVELOPED LVSD. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747518 PERICARDIOCENTESIS KIT FLUID DRAINAGE TRAY PXU MERIT MEDICAL RICHMOND T3124395

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L