MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. DURAFLOW 2; CATHETER, HEMODIALYSIS, IMPLANTED, PRODUCT CODE: MSD

Catalog Number	H787103012015/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
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 review was performed and yielded no exception documents that would cause or contribute to the reported failure.The complaint could not be confirmed and root cause could not be determined.
Event or Problem Description
Customer reports placement went well, but a couple days later when the patient went for dialysis, they noticed the catheter was clogged.The patient was brought back to have the catheter replaced on (b)(6) 2024.There was no injury to the patient.No additional details provided.
Additional Manufacturer Narrative
Correction: h6 removed b code 3331 as we inadvertently reported this as a known lot number when it was not provided.H6 changed d code from 4322 to 11.Additional information: d6a added implant date.D8 selected unknown.The suspect device was not returned for evaluation.A lot number was not provided therefore a dhr review could not be performed.The complaint could not be confirmed and root cause could not be determined.

• Brand Name: DURAFLOW 2
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED, PRODUCT CODE: MSD
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; 19970-b roberto de la madrid; tijuana bc, 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; 19970-b roberto de la madrid; tijuana bc, 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 24723839
• Report Number: 1721504-2026-00109
• Device Sequence Number: 15988786
• Product Code: MSD
• UDI-Device Identifier: 00884450786116
• UDI-Public: 00884450786116
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H787103012015/A
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown