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

Catalog Number	H965103038041
Medical Device Problem Codes	Break (1069); Defective Device (2588); Infusion or Flow Problem (2964); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record or the complaint database could not be performed as no lot number was provided.Should the device return for evaluation the complaint investigation will be re-opened.
Event or Problem Description
The account alleges a patient came into the emergency room because a clamp on the dialysis catheter had broken.A temporary clamp was placed in by the emergency room.The patient was then transferred to interventional radiology to have the broken clamp replaced.The catheter was successfully repaired.No additional patient consequence to report.
Additional Manufacturer Narrative
G2 added other "medwatch mw5172076".
Event or Problem Description
Medwatch mw5172076 received from the fda reports that the patient was presented to the emergency room from a skilled nursing facility; dialysis was provided through a contract with a 3rd party; the patient had a catheter placed and the patient came in for a broken clamp on the limb, and had a temporary clamp in place, and went to the emergency department.An interventional radiologist replaced the broken clamp at bedside, cut the lumen off right behind the hub, used the repair kit, replaced the catheter limb with a repair kit the next day, and the catheter was repaired.Specific information about the repair procedure was not provide, but there was no need for both limbs to be repaired since it was the clamp part from the catheter that was repaired.The venous limb of the catheter was the side where the clamp was repaired.There was no documentation to indicate the catheter had been repaired or altered again after that date.Connections were tight and were checked.The catheter was in use for several months after the repair.There was no reported patient outcome.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BIOFLO CHRONIC DIALYSIS CATHETER
• 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
• MDR Report Key: 22650589
• Report Number: 1721504-2025-00204
• Device Sequence Number: 8798351
• Product Code: MSD
• UDI-Device Identifier: 00884450793831
• UDI-Public: 00884450793831
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H965103038041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 03/31/2026
• 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