MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. BIOFLO DURAMAX; DOUBLE-LUMEN HAEMODIALYSIS CATHETER, IMPLANTABLE

Catalog Number	H965103028051
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
The account alleges that during dialysis treatment with a bioflo duramax 15.5f 32 cm dual-valve sheath catheter kit, leakage was observed near the luer neck.Blood leakage occurred from the arterial limb, resulting in termination of the dialysis treatment.The catheter was exchanged with another device.Device evaluation confirmed a fracture/hole in the extension tubing adjacent to the arterial hub luer.Investigation determined the most likely cause to be over-torquing of the extension tubing-to-luer hub junction during cleaning or handling.No manufacturing or assembly deviations were identified in the device history record.

• Brand Name: BIOFLO DURAMAX
• Common Device Name: DOUBLE-LUMEN HAEMODIALYSIS CATHETER, IMPLANTABLE
• 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: 24582983
• Report Number: 1721504-2026-00912
• Device Sequence Number: 18449923
• Product Code: MSD
• UDI-Device Identifier: 00884450793220
• UDI-Public: 00884450793220
• Combination Product (Y/N): N
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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
• Device Catalogue Number: H965103028051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female