MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. FREE-FLOW® TEMPORARY HEMODIALYSIS; ST FREE FLOW

Model Number	MFFS1520S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation and no photographs provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured, assembled, and inspected according to specification with no non-conformances or abnormalities.The contract manufacturer's supplier also conducted a review of the manufacture records for the lot number reported.Their investigation also revealed the device was manufactured according to specification.Their investigation included tests of devices from the same lot for connection force, rupture, and bending.All were within specification.Without an evaluation of the device a root cause cannot be determined but is not likely manufacturing related.The instructions for use (ifu) contains the following warnings: do not advance the guidewire or catheter if unusual resistance is encountered.Do not insert or withdraw the guidewire forcibly from any component.The wire may break or unravel.If the guidewire becomes damaged, the catheter and guidewire must be removed together.When introducer needle is used, do not withdraw guidewire against needle bevel to avoid possible severing of guidewire.Insufficient tissue dilation can cause compression of the catheter lumen against the guidewire causing difficulty in the insertion and removal of the guidewire from the catheter.This can lead to bending of the guidewire.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
An investigation has been initiated.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Dialysis catheter was placed according to routine by an experienced inserter.Control x-ray done where the catheter is visible on follow-up examination but not noted on primary x-ray.6 days later the catheter is seen on ultrasound examination of the heart.Removed endovascularly without complications.

• Brand Name: FREE-FLOW® TEMPORARY HEMODIALYSIS
• Common Device Name: ST FREE FLOW
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 22141521
• Report Number: 2518902-2025-00035
• Device Sequence Number: 7023233
• Product Code: MPB
• UDI-Device Identifier: 00884908030563
• UDI-Public: (01)00884908030563(17)270930(10)MRMA100
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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?: No
• Operator of Device: Other
• Device Model Number: MFFS1520S
• Device Catalogue Number: MFFS1520S
• Device Lot Number: MRMA100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male