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	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Red end of tunnel hd catheter flushed well, but upon trying to put yellow end caps they would not thread on despite numerous attempts, faulty threads.No harm to patient.

• Brand Name: HEMO-FLOW
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 21167509
• Report Number: 21167509
• Device Sequence Number: 4276326
• Product Code: MSD
• UDI-Device Identifier: 00884908140996
• UDI-Public: (01)00884908140996
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/14/2025
• Report Date (Section F): 01/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: DHFS 28
• Device Catalogue Number: DHFS 28
• Device Lot Number: MRMN940
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/14/2025