MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. HEMO-FLOW; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	DHFS 28
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with coronary artery disease and recent bleed from dialysis catheter.Procedure: tunneled hemodialysis venous catheter placement with fluoroscopy and ultrasound.The distal catheter split when putting the tunneler on.Removed and no known harm to patient.Manufacturer response for catheter, hemodialysis, implanted, hemo-flow (per site reporter).Will obtain.

• Brand Name: HEMO-FLOW
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 3088 east 33rd place; yuma AZ 85365
• MDR Report Key: 19770671
• Report Number: 19770671
• Device Sequence Number: 12912615
• Product Code: MSD
• UDI-Device Identifier: 00884908140996
• UDI-Public: (01)00884908140996(17)260511MRGV720
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/20/2024
• Report Date (Section F): 06/20/2024

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 Model Number: DHFS 28
• Device Catalogue Number: DHFS 28
• Device Lot Number: MRGV720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Date Report Sent to FDA: 06/20/2024