MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. DIGNITY® MINI CT PORT; DIGNITY CT PORT

Model Number	MRDP50AXS
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient seen for a flow study of her port.Ir pa (b)(6) performed study that showed leaking of the contrast from posterior part of the port reservoir.Patient to operating room on (b)(6) for port removal and new port placement.Visible and palpable "hole" in hard plastic backing of port.
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.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 device was not returned for evaluation, and no photographs were provided.Multiple requests for additional information and device return were not successful.Without an evaluation of the device the complaint cannot be confirmed, and a root cause cannot be determined.The device was implanted 8.5 months prior to the reported issue making a manufacturing issue unlikely.Product validation determined the average force required to pierce the port base floor with 19 and 22gauge huber style needles.For the 19 gauge needle the average force was 15.91 lbs with a minimum force of 14 lbs.For the 22 gauge needles the needles bent at an average force of 4.62 lbs and did not penetrate the base floor.We are unable to determine the cause of this event.Excessive force may have been used when accessing the port.The health professional inserting the needle into the port may have misjudged the depth of the port and the amount of force necessary to access the port, thus causing the needle to go through the port base.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: DIGNITY® MINI CT 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: 23371833
• Report Number: 2518902-2025-00061
• Device Sequence Number: 13249500
• Product Code: LJT
• UDI-Device Identifier: 00884908149753
• UDI-Public: (01)00884908149753(17)290331(10)MRKW490
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K132177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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?: No
• Operator of Device: Other
• Device Model Number: MRDP50AXS
• Device Catalogue Number: MRDP50AXS
• Device Lot Number: MRKW490
• Was Device Available for Evaluation?: Yes
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2024
• 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: 24 MO
• Patient Sex: Female
• Patient Weight: 12 KG