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

Model Number	MRDP80AMN
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Removing port-port separated from catheter.Was able to grab the catheter with hemostat and remove.The cuff/collar was adhered into the tract.It separated from the port and the catheter.Patient has to return to have a surgeon dissect the collar from the tract 2 weeks later.

• 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: 8178651
• Report Number: 2518902-2018-00066
• Device Sequence Number: 1332503
• Product Code: LJT
• UDI-Device Identifier: 00884908110296
• UDI-Public: 884908110296
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K132177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: Health Professional
• Device Model Number: MRDP80AMN
• Device Catalogue Number: MRDP80AMN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/19/2018
• 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: 56 YR