MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ONE-STEP CENTESIS CATHETER

Catalog Number	TAPS-5F-10LT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause could not 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.
Event or Problem Description
The account alleges the valve on the one step separated from the hub.No patient injury reported.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.However, a photograph of the defect was provided.The photograph was reviewed and the complaint was confirmed.Root cause is determined to be due to the manufacturing process.A review of the device history record was performed and no exception documents were identified.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: ONE-STEP CENTESIS CATHETER
• Common Device Name: CENTESIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 901 moorefield park dr; #103; north chesterfield VA 23236
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 901 moorefield park dr; #103; north chesterfield VA 23236
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22061196
• Report Number: 1125782-2025-00005
• Device Sequence Number: 15572789
• Product Code: PXI
• UDI-Device Identifier: 00884450038741
• UDI-Public: 00884450038741
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 06/24/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2025
• Device Catalogue Number: TAPS-5F-10LT
• Device Lot Number: T3126550
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• 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
• Patient Sex: Unknown