MAUDE Adverse Event Report: MEDCOMP 6.6F DIGNITY LOW PROFILE CT PORT; DIGNITY CT PORT

Model Number	MRCTI66041
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	02/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.The device has not yet been returned for evaluation.Once the device is received an evaluation will be performed.
Event or Problem Description
X-ray revealed extravasation of contrast around the drum during infusion.
Additional Manufacturer Narrative
One 6.6f dignity port was received.Inspection of the returned device shows a small leak on the base of the device in the upper portion of the "c" in the ct mark.The septum was removed and the inside of the port base was examined.A photograph taken under 10x magnification shows the floor of the port is gouged, possibly by a needle.Issue does not appear to be manufacturing related.Contract manufacturer conducted a record review of the dhr and manufacture process for this lot.The device was manufactured per specifications, no non-conformances or variances were noted.Information regarding the type of needle used with the port, if the needle was left in places or removed after each treatment, and how long the port was implanted was requested of the facility but was not provided.Without the requested information, the root cause for the failure could not be determined.

• Brand Name: 6.6F DIGNITY LOW PROFILE CT PORT
• Common Device Name: DIGNITY CT PORT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8445184
• Report Number: 2518902-2019-00018
• Device Sequence Number: 10851245
• Product Code: LJT
• UDI-Device Identifier: 00884908031157
• UDI-Public: 884908031157
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K132177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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: 03/31/2022
• Device Model Number: MRCTI66041
• Device Catalogue Number: MRCTI66041
• Device Lot Number: MJMG080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention