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

Catalog Number	PC101/JPB
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: PERICARDIOCENTESIS KIT
• Common Device Name: FLUID DRAINAGE TRAY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 12701 kingston ave; chester VA 23836
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 12701 kingston ave; chester VA 23836
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23587237
• Report Number: 1721504-2025-00602
• Device Sequence Number: 15835770
• Product Code: PXU
• UDI-Device Identifier: 00884450015278
• UDI-Public: 00884450015278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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
• Device Catalogue Number: PC101/JPB
• Device Lot Number: T3088168
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown