MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO BIOFLO DURAMAX; HEMODIALYSIS CATHETER

Catalog Number	H965103028041/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that the peel away wing snapped off while trying to peel the catheter away.The peel away was removed with hemostats.No patient injury.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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 dhr review was performed and yielded no exception documents that would cause or contribute to the reported failure.A search of the complaint database was performed and only one similar complaint was identified.
Additional Manufacturer Narrative
H6: updated.H11: product evaluation.No physical units were returned for evaluation in relation to this complaint.However, the customer submitted photographic evidence that confirms that the two affected units show signs of clinical use and failed split, characterized by an irregular, wavy deformation at the onset of splitting.Based on this evidence, the complaint is confirmed.Due to the absence of physical samples, it was not possible to verify whether the defective units lacked the required scoring line (indicative of a segregation error) or whether the scoring was present but improperly executed (potentially due to incorrect scoring machine settings).The root cause remains inconclusive at this time.A dhr review was performed and yielded no exception documents that would cause or contribute to the reported failure.A search of the complaint database was performed and one similar complaint was identified.

• Brand Name: BIOFLO DURAMAX
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 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
• MDR Report Key: 22286385
• Report Number: 1721504-2025-00091
• Device Sequence Number: 8930111
• Product Code: MSD
• UDI-Device Identifier: 00884450786253
• UDI-Public: 00884450786253
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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 Catalogue Number: H965103028041/A
• Device Lot Number: I3178899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/16/2025; Not provided
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/22/2025; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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