MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F DIGNITY CT PORT

Model Number	MICTI50041M
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with dignity 5f port on the right arm undergoing treatment with anticancer chemotherapy.As extravasation due to catheter injury is suspected, the device is removed and a partial catheter injury is found, approximately 6-7cm form the connection between reservoir and catheter.
Additional Manufacturer Narrative
An investigation has been initiated.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 dignity port was returned for evaluation with the lock and lumen still attached.A functional test was performed, and the complaint was confirmed.A small leak was noted in the lumen between the 27 and 28 cm marks.Under magnification the lumen appears to have been pinched at the location of the leak.No lot number was provided.Without a lot number a review of the manufacture records is not possible.The device was in use for more than 3 1/2 years with no reported issues.A definitive root cause cannot be determined but is not likely manufacture related.Potential causes for lumen leaks include excessive pressure, i.E flushing/infusion against resistance, and pinch off.The instructions for use (ifu) contain the following warnings, precautions, and statements: do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure.Do not use a syringe smaller than 10ml.Prolonged infusion pressure greater than 25 psi may cause damage to a patient's vessels or viscus.Failure to ensure patency of the catheter prior to power injection studies may result in port system failure.Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.Exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement.Do not exceed a 325-psi pressure limit setting, or the maximum flow rate setting on the power injection machine, if power injecting through the power injectable implantable infusion port device.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: 5F DIGNITY CT PORT
• Common Device Name: DIGNITY 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: 18536119
• Report Number: 2518902-2024-00006
• Device Sequence Number: 6778927
• Product Code: LJT
• UDI-Device Identifier: 00884908089639
• UDI-Public: 00884908089639
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 03/25/2024

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: MICTI50041M
• Device Catalogue Number: MICTI50041M
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/25/2024
• 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 Sex: Unknown