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

Model Number	MICTI50041M
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Codes	Extravasation (1842); Swelling/ Edema (4577)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
During scheduled irrigation with saline solution of the port, swelling of the subcutaneous tissue appears due to suspected extravasation.After the x-ray verification of the integrity of the catheter in the thoracic and brachial tract, the device was removed with almost total breakage detected 2 cm from the reservoir in the subcutaneous section of the catheter with another small lesion 0.5 cm from the previous one.Device was implanted (b)(6) 2021.No problems with the device during previous administrations of anti-tumor therapy.Use suspended for more than one year prior to this event.
Additional Manufacturer Narrative
The 5f dignity port was returned with the lumen and lock attached.Visual inspection revealed a kink and a tear 1.5 cm distal to the lock, with another tear 1 cm from the first tear.Clotted blood was noted in the lumen forming obstructions.The blood in the lumen could not be removed during decontamination or by inserting a guidewire through the distal tip of the lumen.Under magnification it appears the lumen burst in both tear locations.The device was implanted for >2 years with no reported issues and use of the device was suspended for more than one year prior to this event.There is no indication if the device was maintained properly during that year of not being used.The clotted blood in the lumen could be indicative that the device was not maintained properly.Excessive external pressure applied to an obstructed lumen may be a contributing cause for this type of failure.Another possible contributing factor is "pinch-off" due to the location of the tears.A definitive root cause could not be determined; however, it is unlikely related to manufacturing.

• 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: 18319301
• Report Number: 2518902-2023-00075
• Device Sequence Number: 17880490
• 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: 2021
• Device Explanted Year: 2023
• 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): 03/11/2024

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 Expiration Date: 05/31/2025
• Device Model Number: MICTI50041M
• Device Catalogue Number: MICTI50041M
• Device Lot Number: MPTD440
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2021
• 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