MAUDE Adverse Event Report: MEDCOMP 8F DIGNITY MS CT PORT; DIGNITY CT-PORT

Model Number	MRDP80AMN
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.
Event or Problem Description
Port was placed in patient.Attempts to aspirate port before suturing failed.Port was injected with contrast which showed leaking from the device.Body of the port was then removed and replaced with a new device.
Additional Manufacturer Narrative
Received an 8f dignity port for evaluation.A visual inspection revealed a no damage or defect to the port.The lumen and lock were not returned for evaluation.The device was forwarded to the device contract manufacturer for evaluation.Based on the sample analysis and the process verification, the root cause could not be found for the reported failure mode.Only the port was returned for investigation.Therefore, the catheter and catheter lock could not be evaluated.The port passed all leak testing and was dimensionally met specifications.We are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 8F DIGNITY MS CT PORT
• Common Device Name: DIGNITY CT-PORT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6638160
• Report Number: 2518902-2017-00024
• Device Sequence Number: 1123506
• Product Code: LJT
• UDI-Device Identifier: 00884908110296
• UDI-Public: 884908110296
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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: 04/29/2021
• Device Model Number: MRDP80AMN
• Device Catalogue Number: MRDP80AMN
• Device Lot Number: MJAG880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 10/23/2017
• 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
• Patient Age: 59 YR