MAUDE Adverse Event Report: MEDCOMP 6.6F PRO-FUSE CT LP ATT POLY; PRO-FUSE CT PORT

Model Number	MRCTT66041
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.We are currently waiting for additional information from the facility.When the investigation is complete a final report will be submitted.
Event or Problem Description
Port leaking medication via holes in the port base and causing pain to child.Port placed mid 2016, removed (b)(6) 2018.
Additional Manufacturer Narrative
Received one 6.6f pro-fuse port for evaluation.The sample was given to the medcomp engineering department for evaluation.A 13.5cm length of lumen connected with the locking collar.A visual examination of the port base revealed 6 raised areas.There is one hole in the port base that leaks when the device is flushed.The interior of the port base shows pitting and gouging.Holes in the base were also noted and measured.The base showed fragmentation/scratches of material near the areas of needle insertion.Information regarding the use of the port and the needles used to access the port was requested.No information was provided.Root cause is undetermined.The risk documentation accounts for port base needle penetration and leak.

• Brand Name: 6.6F PRO-FUSE CT LP ATT POLY
• Common Device Name: PRO-FUSE CT PORT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8038303
• Report Number: 2518902-2018-00057
• Device Sequence Number: 11121712
• Product Code: LJT
• UDI-Device Identifier: 00884908031355
• UDI-Public: 884908031355
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K132177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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 Model Number: MRCTT66041
• Device Catalogue Number: MRCTT66041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 02/21/2019
• 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