MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15.5F X 20CM ST FREE-FLOW IJ

Model Number	MFFS1520IJ
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During ct with contrast power injector, the clear venous tube widens and get leaking.
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.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
The free flow catheter was returned in two pieces.The catheter had been cut at the start of the curved section.Visual inspection revealed the venous extension tubing is expanded, twisted, and collapsed.A functional test revealed no leaks but did reveal the extension tubing balloons when flushed.When the syringe is detached, the tubing collapses on itself.The information provided states the issue occurred "during ct with contrast power injector".The free flow catheter is not approved or indicated for power injection.The condition of the returned device indicates the power injection exerted pressure on the extension tubing that far exceeds what the device is designed to withstand, causing the tubing to expand to the point of weakening its structure, which resulted in collapsing on itself.Power injection through the free flow catheter is an off-label use.This is user error.No further investigation is necessary.The instructions for use state the following.Indications for us: the st catheter is indicated for use in attaining short-term vascular access for hemodialysis, hemofiltration, and apheresis.Contraindications: the catheter is intended for short-term vascular access only and should not be used for any purpose other than indicated in these instructions.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.

• Brand Name: 15.5F X 20CM ST FREE-FLOW IJ
• Common Device Name: ST FREE-FLOW IJ
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 19309228
• Report Number: 2518902-2024-00039
• Device Sequence Number: 6911111
• Product Code: MPB
• UDI-Device Identifier: 00884908030525
• UDI-Public: 00884908030525
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/23/2024

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: MFFS1520IJ
• Device Catalogue Number: MFFS1520IJ
• Device Lot Number: MMKM530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 86 KG