MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. DURAFLOW2; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	H787103012015
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was identified during internal quality system activities.Upon review, the manufacturer determined the event meets fda criteria for reporting.The report is being submitted to ensure accuracy and completeness of mdr files.This submission does not reflect a change in device performance or patient risk.The awareness date corresponds to when the manufacturer became aware of the event details.All information reasonably known to the manufacturer at this time has been included.The suspect device was not returned for evaluation.A dhr search could not be performed because no lot number was reported.The complaint could not be confirmed, and the root cause could not be determined.
Event or Problem Description
The customer reports patient initially had a dialysis catheter placed femoraly on (b)(6) 2024.Patient was admitted to the icu and when running dialysis, the nurse noticed that the catheter had slipped through the rotating suture wings and was coming outside the body in the groin area.The patient had to have the catheter replaced.Patient was 4 feet 9" which is why a shorter catheter was used.
Additional Manufacturer Narrative
Corrected d4.Additional information added d8 and g1 manufacturing site.

• Brand Name: DURAFLOW2
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: mr. cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 24644212
• Report Number: 1721504-2026-00100
• Device Sequence Number: 9906377
• Product Code: MSD
• UDI-Device Identifier: 00884450786116
• UDI-Public: 00884450786116
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110936
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: H787103012015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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