MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. MEDCOMP® PLASTIC POWER INJECTABLE INFUSION PORT; DIGNITY CT-PORT

Model Number	MRDP80AMS
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ir brought patient for port check.Port not giving blood return.Catheter was detached from port under flouro.Port, locking mechanism, and catheter were retrieved from patient.Locking collar was on port.Not sure if catheter was locked.
Additional Manufacturer Narrative
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 port was returned for evaluation with the lumen detached.The port lock was assembled on the lumen.Relative measurements were taken of the port stem and found to be within specification.After decontamination the lumen was attached to the port stem according to ifu instructions and the locking collar snapped into place.The lumen was then pulled with force but did not detach from the stem.No failure was found with the returned devices.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the port, port lumen, and lumen lock were manufactured and inspected according to specification with no non-conformances or abnormalities.We are unable to determine the cause for the disconnection of the lumen from the port.Incorrect assembly of the lumen to the port during implantation could be a contributing factor.The instructions for use (ifu) provided with the kit clearly identify the steps to be taken to attach the catheter to the port.Any deviation could potentially lead to a disconnection of the catheter or catheter lock.The ifu states the catheter should be advanced "just up to the second rib", not over the second rib.Also noted in the ifu, "advancing catheter too far along port stem could lead to "mushrooming" of tubing when the catheter lock is advanced." this could prevent the catheter lock from fully engaging on the port stem.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: MEDCOMP® PLASTIC POWER INJECTABLE INFUSION PORT
• Common Device Name: DIGNITY CT-PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 21917508
• Report Number: 2518902-2025-00019
• Device Sequence Number: 18399984
• Product Code: LJT
• UDI-Device Identifier: 00884908149081
• UDI-Public: (01)00884908149081(17)290731(10)MRRR870
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: MRDP80AMS
• Device Catalogue Number: MRDP80AMS
• Device Lot Number: MRRR870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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