MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. MEDCOMP® GEN III POWER INJECTABLE PORT; DIGNITY CT-PORT

Model Number	MRDP80AMN
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
When the port was accessed and flushed it was noted to leak blood and iv fluids from the access site.The tissue around the port also noted to swell with fluids flushed.The port was removed and inspected.A round hole was noted on the back side of the port located right between the letters "c" and "t".
Additional Manufacturer Narrative
The device was not returned for evaluation.One photograph and one video were provided showing a hole in the port base and leakage from that hole.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured, assembled, and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as the last step in the manufacture process.This test would have detected any holes, ruptures, tears and/or small pin holes that could cause a leak if it had existed at the time of manufacture.The device was implanted for more than 6 months and functioned as intended with no issues reported.A possible cause for this type of failure is the use of a non-approved needle to access the port, such as a trocar needle.The round cannula that would be left in the port strongly resembles the size and shape of the picture of the hole in the port.Repeatedly puncturing the port in the same location, and leaving the port accessed may damage the base of the port leading to the formation of a hole.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.Without an evaluation of the actual device involved a definitive root cause could not be determined but is unlikely to be manufacturing related.Product validation determined the average force required to pierce the port base floor with 19- and 22-gauge 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.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: MEDCOMP® GEN III POWER INJECTABLE 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: 20494552
• Report Number: 2518902-2024-00069
• Device Sequence Number: 4096008
• Product Code: LJT
• UDI-Device Identifier: 00884908149074
• UDI-Public: 00884908149074
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K132177
• 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
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: MRDP80AMN
• Device Catalogue Number: MRDP80AMN
• Device Lot Number: MQMY970
• Was Device Available for Evaluation?: No
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 110 KG