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

Catalog Number	H965103038041
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/10/2023
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 therefore the complaint could not be confirmed and 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.
Event or Problem Description
A search in the adverse event notifications (daen) database, report number (b)(4), reported that "a crack was noticed on one of the lumens of the catheter as it leaked during flushing and air aspirated when the clamps were on." no further information was provided.

• Brand Name: BIOFLO DURAMAX
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 24688208
• Report Number: 1721504-2026-00176
• Device Sequence Number: 15953555
• Product Code: MSD
• UDI-Device Identifier: 00884450793831
• UDI-Public: 00884450793831
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: H965103038041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 03/25/2026
• 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