MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 6.6F DIGNITY LOW PROFILE CT PORT; DIGNITY CT PORT

Model Number	MRCTI66041
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for additional information.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
The contrast medium injected into the reservoir showed leakage just in the proximal portion adjacent to it in the pectoral region, an upper path apparently external to the catheter was also observed, with a greater quantity flowing to the cervical region.These findings suggest impairment of the reservoir or even the proximal portion of the catheter, which may be related to obstruction, fracture or even disconnection.
Additional Manufacturer Narrative
No device was returned.A photograph was provided showing what appears to be a slice in the lumen, indicative of being cut with a sharp instrument.The slice/cut appears to be at an angle and through approximately 3/4 of the lumen diameter.As the lumen is implanted fully in the patient it is not exposed to sharp objects.It is not known if the device was checked for nicks or small cuts prior to insertion.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured according to specification with no non-conformances or abnormalities.The device was inspected according to specification as well.This inspection included a 100% leak test of the device.This test would have detected the leak if it had occurred during the manufacture process.Without an evaluation of the device a root cause cannot be determined.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: 6.6F DIGNITY LOW PROFILE CT PORT
• Common Device Name: DIGNITY CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11709637
• Report Number: 2518902-2021-00022
• Device Sequence Number: 14237474
• Product Code: LJT
• UDI-Device Identifier: 00884908031157
• UDI-Public: 884908031157
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: 03/31/2024
• Device Model Number: MRCTI66041
• Device Catalogue Number: MRCTI66041
• Device Lot Number: MPAG120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/22/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention