MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. DIGNITY® LOW PROFILE CT PORT; CT-PORT

Model Number	MRDP66PLN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Device was broken (lumen broke) which was why the procedure was needed for port placement.
Additional Manufacturer Narrative
The port was returned with approximately 8 cm of lumen attached.An additional 7.5 cm of lumen was also returned with sutures sewn into the proximal end, near the 8 cm mark.It is unknown why sutures would be attached to the lumen at this point.Visual inspection revealed the end of the separate lumen with the sutures appears to be the end that was once connected to the attached lumen.Functional testing was performed by clamping the distal end of the attached lumen and flushing the port with a huber needle.No leaks were noted.Although clarification and additional information regarding what was "broken" and where was requested it was not provided.It is suspected the reported "break" occurred at the location where the sutures were applied but cannot be verified.The contract manufacturer conducted a review of the manufacture records for the lot number reported.The review performed to final assembly level for the port lumen did not show anything out of specification, no authorized manufacture variances, non-conformance reports or reworks related to the reported failure mode.The device was manufactured according to specifications.Without the requested clarification and additional information, a definitive root cause cannot be determined.The device was implanted and functioned for four years making it likely manufacturing 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: DIGNITY® LOW PROFILE CT PORT
• Common Device Name: 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: 21515795
• Report Number: 2518902-2025-00012
• Device Sequence Number: 4590647
• Product Code: LJT
• UDI-Device Identifier: 00884908149883
• UDI-Public: 00884908149883
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: MRDP66PLN
• Device Catalogue Number: MRDP66PLN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2020
• 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: 10 YR
• Patient Sex: Male
• Patient Weight: 18 KG