BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERICARDIOCENTESIS KIT

    MDR report key: 23587237 · Received November 18, 2025

    Report

    Report Number
    1721504-2025-00602
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 25, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    PXU
    UDI-DI
    00884450015278
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONLY THE HUB AND STRAIN RELIEF COMPONENTS OF THE SUSPECT DEVICE WERE RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE IS ATTRIBUTED TO MISALIGNMENT OF THE STRAIN RELIEF DURING THE MANUFACTURING PROCESS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND TWO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    UPDATE AS OF (B)(6) 2025: THE BROKEN FRAGMENT HAS BEEN RETRIEVED BUT DISCARDED BY THE CUSTOMER FACILITY. DETAILS REGARDING THE DATE, TIME, AND METHOD FOR RETRIEVAL ARE UNKNOWN AS IT WAS DIFFICULT FOR THE CUSTOMER TO PROVIDE.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING USE OF THE PERICARDIOCENTESIS KIT, THE CATHETER BROKE LEAVING THE TIP WITHIN THE PERICARDIUM. THE BREAK OCCURRED WHEN THE CATHETER WAS PULLED DURING INSERTION. THE BROKEN FRAGMENT IS SCHEDULE FOR RETRIEVAL. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325410 PERICARDIOCENTESIS KIT FLUID DRAINAGE TRAY PXU MERIT MEDICAL SYSTEMS, INC. T3088168 00884450015278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention