MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ONESTEP PARACENTESIS KIT

Catalog Number	K12T-05687D
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to be returned for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were identified.
Event or Problem Description
The account alleges that the hub of the catheter broke off inside of the patient.The broken piece was not removed from patient.

• Brand Name: ONESTEP PARACENTESIS KIT
• Common Device Name: PARACENTESIS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 12701 n kingston ave; chester VA 23836
• Manufacturer Contact: adrian cole ; 1600 west merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 22384437
• Report Number: 1721504-2025-00122
• Device Sequence Number: 15657995
• Product Code: OEQ
• UDI-Device Identifier: 00884450261651
• UDI-Public: 00884450261651
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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 Expiration Date: 03/26/2026
• Device Catalogue Number: K12T-05687D
• Device Lot Number: T3217499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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
• Patient Sex: Unknown