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

Model Number	MRDP66AMN
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented to vir (vascular and interventional radiology) for right chest wall port removal.Upon imaging in vir noted that medical device was broken and catheter was free floating in the patient's heart/chest and hub was maintained in right chest wall.
Additional Manufacturer Narrative
An investigation has been initiated.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 involved was not returned for evaluation.Without sufficient information, or an evaluation of the device involved, we are unable to determine the root cause or factors that may have contributed to this event.Information from the facility indicated the port was implanted in 2022 with no reported issues until now.A manufacturing issue is unlikely due to the length of implantation.Without sufficient information, or an evaluation of the device involved, we are unable to determine the root cause or factors that may have contributed to this event.Care and maintenance of the device is unknown.Possible complications listed in the instructions for use include- catheter embolism, catheter occlusion, catheter occlusion, damage or breakage due compression between the clavicle and first rib.The ifu also includes the following- if the port remains unused for long periods of time, the heparin lock should be changed at least every four weeks.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DIGNITY®
• 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: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 20501484
• Report Number: 2518902-2024-00072
• Device Sequence Number: 8419927
• Product Code: LJT
• UDI-Device Identifier: 00884908149845
• UDI-Public: 00884908149845
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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?: No
• Operator of Device: Other
• Device Model Number: MRDP66AMN
• Device Catalogue Number: MRDP66AMN
• Device Lot Number: MQHW200
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 46 KG