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

Catalog Number	H965103028041
Medical Device Problem Codes	Separation Failure (2547); Activation, Positioning or Separation Problem (2906); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The scoring of the unit was not deep enough in the sheath, which caused the wavy shapes in the sheath.This is due to a problem in the adjustment of the scoring machine.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
Event or Problem Description
The account alleges that when inserting the permcath during an operation, the peel away sheath could not be removed properly.No patient injury.

• Brand Name: BIOFLO DURAMAX®
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• 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: 22302775
• Report Number: 1721504-2025-00104
• Device Sequence Number: 8091652
• Product Code: MSD
• UDI-Device Identifier: 00884450786253
• UDI-Public: 00884450786253
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: H965103028041
• Device Lot Number: 5807390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown