MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC PARACENTESIS PROCEDURE TRAY; CLOSED-WOUND DRAIN

Catalog Number	SPPT-5F-7L
Medical Device Problem Codes	Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that during a therapeutic paracentesis procedure, the physician reported that the catheter was not draining.Upon removal of the device, it was noted that the catheter tip was missing.Ultrasound imaging confirmed that the catheter tip was retained in the subcutaneous tissue of the right lower quadrant of the abdomen.Surgical consultation was obtained and removal of the retained fragment was scheduled.The device and packaging were not retained for evaluation.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: PARACENTESIS PROCEDURE TRAY
• Common Device Name: CLOSED-WOUND DRAIN
• 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: 24583327
• Report Number: 1721504-2026-00920
• Device Sequence Number: 10355671
• Product Code: PYC
• UDI-Device Identifier: 00884450038710
• UDI-Public: 00884450038710
• Combination Product (Y/N): Y
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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: SPPT-5F-7L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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