MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ONESTEP; SINGLE USE INSTRUMENT TRAY

Catalog Number	SPPT-5F-7L
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Account reported the one-step 5 french 7c 8mm catheter was being used during a radiological procedure.The provider noted that the catheter was not draining during a routine therapeutic paracentesis.The doctor removed the catheter and discovered that the tip of the catheter was no longer present.Ultrasound showed that the tip was retained and present in the subcutaneous tissue of the right lower quadrant of the abdomen.Surgery was consulted and scheduled.Unfortunately, neither the packaging or the catheter itself was saved by the diagnostic radiology staff.

• Brand Name: ONESTEP
• Common Device Name: SINGLE USE INSTRUMENT TRAY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 24550807
• Report Number: 1721504-2026-00905
• Device Sequence Number: 20256184
• Product Code: OJV
• UDI-Device Identifier: 00884450038710
• UDI-Public: 00884450038710
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: 02/11/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• 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