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

Catalog Number	H787103028045/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
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 customer returned three unopened duramax trays part number h787103028045/a and lot number i3072554 for investigation due to a device malfunction (failed split).A visual inspection of the returned units noted no damages were observed.The split test was performed on all three sheaths and the sheaths split evenly.The devices performed as intended and was manufactured per merit medical specifications.The device history record showed that the lot was released accomplishing all quality standard requirements.There was no deviation and non-conforming reported during the manufacturing of this product.Since the sheaths arrived in intact condition, splitted and performed as intended, therefore the root cause remains unknown.
Event or Problem Description
The customer reports that the peel away sheath would not peel properly resulting in opening additional supplies.There was no patient injury.

• Brand Name: DURAMAX®
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 24673896
• Report Number: 1721504-2026-00172
• Device Sequence Number: 16042269
• Product Code: MSD
• UDI-Device Identifier: 00884450786161
• UDI-Public: 00884450786161
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K101843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: H787103028045/A
• Device Lot Number: I3072554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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