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

Model Number MICTI50041M

Device Problems Break (1069); Flushing Problem (1252); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 307041897
• Report Number: 2518902-2022-00069
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00884908089639
• UDI-Public: 00884908089639
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• 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
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female