MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F DIGNITY LP CT-PORT; DIGNITY CT-PORT

Model Number	MRDP80ALN
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the customer medwatch indicates the device was returned to the manufacturer it was not received at medcomp headquarters or medcomp warehouse.Multiple attempts for additional information were not successful.The contract manufacturer conducted a review of the manufacture records for the lot number provided.Their investigation revealed the catheter lumen was manufactured, inspected, and packaged according to specification with no non-conformances or abnormalities.Without additional information and an evaluation of the device a root cause cannot be determined.The instructions for use (ifu) contains the following warnings and precautions: take care not to perforate, tear, or fracture the catheter during placement.After assembling catheter to port, check assembly for leaks or damage.Do not exceed a 325 psi pressure limit setting, or the maximum flow rate setting on the power injection machine, if power injecting through the power injectable implantable infusion port device.Failure to ensure patency of the catheter prior to power injection studies may result in port system failure.Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.Exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement.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
Information received from facility voluntary medwatch (b)(4).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
Patient port noted to be leaking and difficult to flush.Venous port fluoro injection done, showing the port tubing broke off of port device and was embolized in the right atrium.Foreign body retrieval completed successfully.

• Brand Name: 8F DIGNITY LP 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: 18302662
• Report Number: 2518902-2023-00074
• Device Sequence Number: 6936300
• Product Code: LJT
• UDI-Device Identifier: 00884908149050
• UDI-Public: 00884908149050
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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 Model Number: MRDP80ALN
• Device Catalogue Number: MRDP80ALN
• Device Lot Number: MQWT590
• Was Device Available for Evaluation?: No
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• 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: Male