BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERICARDIOCENTESIS KIT

    MDR report key: 22330211 · Received June 25, 2025

    Report

    Report Number
    1721504-2025-00116
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 11, 2025
    Report Date
    August 7, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    PXU
    UDI-DI
    00884450015278
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED 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 THE PATIENT UNDERWENT PERICARDIOCENTESIS WITHOUT ANY PROCEDURAL COMPLICATIONS. A FOLLOW UP CHEST X-RAY DEMONSTRATED A PNEUMOPERITONEUM. SUBSEQUENT CT SCAN CONFIRMED THIS WITH NO OBVIOUS PERFORATION. CONCERN IS THAT AIR WAS INTRODUCED BECAUSE OF A FAULTY STOPCOCK (3-WAY TAP) OR CONNECTION. NO ADDITIONAL PATIENT CONSEQUENCE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129184 PERICARDIOCENTESIS KIT FLUID DRAINAGE TRAY PXU MERIT MEDICAL SYSTEMS INC. T3124395 00884450015278

    Patients

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