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

Catalog Number	H965103028031
Medical Device Problem Codes	Product Quality Problem (1506); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
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 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.
Additional Manufacturer Narrative
D1, d2, d3 and d4 corrected product information and manufacturer address.D9 updated.G1 corrected manufacturing site for devices address.G4 corrected pma/510(k) number.H4 added date.H10 added related report numbers.H11 product evaluation.The customer returned an unopened bioflo duramax tray part number h965103028030 (according to pouch label) and lot number 5810281 for investigation due to the tear-away sheath not being properly trimmed.Upon a visual inspection of the returned unit, no damages were observed.The split test was performed on the dpro sheath and the sheath split evenly.The device performed as intended.Since the sheath arrived in intact condition, splitted and performed as intended, therefore the root cause remains unknown.

• 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 - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21913116
• Report Number: 3011642792-2025-00053
• Device Sequence Number: 15576521
• Product Code: MSD
• UDI-Device Identifier: 00884450786215
• UDI-Public: 00884450786215
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Followup,Followup
• Report Date (Section B): 03/31/2026

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 Expiration Date: 08/31/2026
• Device Catalogue Number: H965103028031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/30/2025; Not provided
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/06/2025; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2024
• 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