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

Model Number	MICTI50041M
Medical Device Problem Codes	Break (1069); Flushing Problem (1252); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2022
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
Device used for chemotherapy.Device not working in aspiration and infusion.Upon removal there is kinking of the catheter body 4 cm from the hub to the chamber.Also presence of cracks in the body and in the connection point on the reservoir.
Additional Manufacturer Narrative
The dignity port was returned with the lumen and lock attached.Visual inspection revealed the distal end of the lock is severely damaged and appears to have been crushed.Closer examination shows marks from an instrument such as a hemostat.It is not known why the lock would have been pinched in this manner or if it occurred during insertion or during device removal.The lumen appears to bend approximately 4.5 cm from the stem but is not kinked as reported.The device flushed and aspirated with no resistance.However, a leak was noted approximately 5 cm from the port stem.Closer inspection of the lumen revealed the leak is coming from a slice approximately 0.2 cm in length.The edges of the slice are smooth, not jagged.This portion of the lumen would have been in the body and not exposed to anything other than fluids.It is possible the lumen was nicked prior to or during insertion, causing a weak spot in the lumen.Over time this weak spot may have opened, causing the issue reported.It cannot be determined when damaged occurred.The device was implanted for 10 months prior to the incident.It is also possible the kink/leak was caused by pinch off.This condition and steps to overcome it are discussed in the instructions for use (ifu).The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a sample inspection of tubing to ensure no kinks or other defects and measurement variations are noted.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: 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: 15869096
• Report Number: 2518902-2022-00069
• Device Sequence Number: 17817404
• 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: 2022
• Device Explanted Year: 2022
• 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): 12/22/2022

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: 02/28/2026
• Device Model Number: MICTI50041M
• Device Catalogue Number: MICTI50041M
• Device Lot Number: MPWH890
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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 Age: 57 YR
• Patient Sex: Female