MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F PRO-FUSE CT PLAST PORT; PRO-FUSE CT PORT

Model Number	MRCTT80001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994)
Type of Reportable Event	Malfunction
Event or Problem Description
Port lumen leaked approximately 5 cm from the port stem.
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 8f pro-fuse port was returned for evaluation.A 22cm segment of lumen is attached to the port stem with a catheter lock.Visual examination of the lumen shows a longitudinal slice in the lumen 6.5cm from the port stem.The slice is 0.5cm in length.The slice leaks when the device is flushed.There is another mark on the lumen perpendicular to the slice.This mark does not leak.A supplier corrective action request was issued to the contract manufacturer for this event.The visual inspection identified two areas of damage to the lumen.The first area presented two perpendicular marks, approximately 0.5 cm long.Of these 2 marks, the lower mark is where the leak was present.The marks/lines appear to have been made by something that pressed this section of the tube, causing these marks to be generated and later the leakage.The second area of damage looks like the tube was twisted, causing this deformation with no leak.A review of the manufacture records for the lot number reported revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The device was implanted and functioned with no issues for one month prior to the reported event.Based on the evaluation of the device and a review of the manufacture records a root cause cannot be determined but is not likely manufacture related.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: 8F PRO-FUSE CT PLAST PORT
• Common Device Name: PRO-FUSE CT PORT
• 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: 17964545
• Report Number: 2518902-2023-00066
• Device Sequence Number: 20474279
• Product Code: LJT
• UDI-Device Identifier: 00884908031379
• UDI-Public: 00884908031379
• Combination Product (Y/N): N
• Initial Reporter Country: NP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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?: Yes
• Operator of Device: Other
• Device Model Number: MRCTT80001
• Device Catalogue Number: MRCTT80001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 80 KG