MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERICARDIOCENTESIS KIT; FLUID DRAINAGE TRAY

Catalog Number	PC101/B
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Pneumoperitoneum (4819)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has not been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: PERICARDIOCENTESIS KIT
• Common Device Name: FLUID DRAINAGE TRAY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22330211
• Report Number: 1721504-2025-00116
• Device Sequence Number: 12837198
• Product Code: PXU
• UDI-Device Identifier: 00884450015278
• UDI-Public: 00884450015278
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PC101/B
• Device Lot Number: T3124395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown