MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F MINI DIGNITY CT PORT; DIGNITY PORT

Model Number	MRCTI50041MP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); Swelling/ Edema (4577)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently waiting 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
Port was not working, and patient had pain and swelling at sight.When port was removed it had a hole in the back of it.
Additional Manufacturer Narrative
The mini dignity port was returned with approximately 18 cm of the lumen attached to the port stem.Visual inspection confirms the complaint as a hole can be seen on the bottom of the port.The material around the hole protrudes outward from the hole, indicating the source of the hole was from inside the port and not an exterior puncture.The septum was removed so that the hole could be viewed from inside the port.The port floor shows multiple scratches and gouges with the one through and through puncture hole.Information obtained from the facility indicates the needle is left insitu for extended periods of time but is to be changed out every 7 days.This could explain the number of scratches/gouges in the port floor.The puncture hole appears to be from a needle that was inserted too far, piercing the base of the port.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.We are unable to determine the cause of this event.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.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.A definitive root cause cannot be determined but is most likely not manufacture 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: 5F MINI DIGNITY CT PORT
• Common Device Name: DIGNITY 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: 15623928
• Report Number: 2518902-2022-00061
• Device Sequence Number: 6460645
• Product Code: LJT
• UDI-Device Identifier: 00884908148954
• UDI-Public: 00884908148954
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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 Expiration Date: 08/31/2023
• Device Model Number: MRCTI50041MP
• Device Catalogue Number: MRCTI50041MP
• Device Lot Number: MQCK680 S2
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/28/2022
• Date Device Manufactured: 02/14/2022
• 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: 20 MO
• Patient Sex: Female
• Patient Weight: 12 KG