MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CENTROSFLO HEMODIALYSIS CATHETER

Catalog Number	CENFP23K/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 cannot be determined.A review of the complaint database was performed and one similar complaint for this lot was identified from the same customer.A review of the device history record was performed and no exception documents were found.If the device is returned at a later date, the complaint will be reopened and a complete investigation will be performed.
Event or Problem Description
The account alleges that the peelaway sheath was difficult to tear, making it difficult to use.

• Brand Name: CENTROSFLO HEMODIALYSIS CATHETER
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22440607
• Report Number: 1721504-2025-00145
• Device Sequence Number: 16934837
• Product Code: MSD
• UDI-Device Identifier: 00884450200025
• UDI-Public: 00884450200025
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K141363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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 Catalogue Number: CENFP23K/A
• Device Lot Number: H3004608
• 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: 07/01/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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