MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 9.5F DIGNITY DUEL LUMEN CT PORT

Model Number	MIDP95ADS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information regarding the incident and for the device to be returned for evaluation.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
(b)(6) 2024 patient resented w/ cp/sob, ct chest ordered after dual port accessed, felt popping sensation w/ injection- of contrast, imaging w/ contrast in left chest sq tissue, evaluated by radiologist and confirmed needle placement and blood return.Port de-accessed d/t pain/ edema around port pocked.Re-accessed on (b)(6) 2024 w/tissue displacement w/ flushing upper lumen via huber needle.(b)(6) 2024 procedure exchange.Port body on the back table: accessed upper port w/ bulging of the reservoir and leaking of saline on the underside of the port body.
Additional Manufacturer Narrative
One dual port was returned for evaluation with approximately 1/5 cm of lumen attached.Visual inspection revealed multiple nicks and deep gouges on one side of the port, as well as multiple nicks on the top of the port body.These marks are indicative of "missing" the septum with the needle.A functional test was conducted by clamping one end of the lumen and attempting to flush the port with a huber needle.No leaks were noted.No lot number was provided.Without the lot number a review of the manufacture records for this device is not possible.Returned device functioned as intended.The device was further reviewed by medcomp engineering.As the returned device presented with no leaks when tested, it is suspected that the multiple deep gouges may suggest that fluids were injected believing the needle was in the port when it was actually alongside the port, thus giving the impression of a leak.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: 9.5F DIGNITY DUEL LUMEN CT PORT
• Common Device Name: DIGNITY DUEL LUMEN 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: 18579267
• Report Number: 2518902-2024-00008
• Device Sequence Number: 15434599
• Product Code: LJT
• UDI-Device Identifier: 00884908115475
• UDI-Public: 00884908115475
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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: MIDP95ADS
• Device Catalogue Number: MIDP95ADS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 102 KG