MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ONE-STEP¿; CATHETER, IRRIGATION

Catalog Number	OSC-6F-10L/C
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
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 preparation of a centesis procedure, the catheter broke at the hub.No patient injury.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually.The hub was observed to be attached to the cap of the catheter.The complaint was not confirmed and no root cause was able to be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were identified.

• Brand Name: ONE-STEP¿
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, ca 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, ca 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 23292622
• Report Number: 1721504-2025-00556
• Device Sequence Number: 10027998
• Product Code: GBX
• UDI-Device Identifier: 00884450536391
• UDI-Public: 00884450536391
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: OSC-6F-10L/C
• Device Lot Number: I3220323
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown