MAUDE Adverse Event Report: MEDCOMP 11.5F X 20CM DUO-FLOW CATHETER; SHORT TERM HEMODIALYSIS CATHETER

Model Number	MCDLT4400
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Additional information has been requested regarding the incident.
Event or Problem Description
Dialysis treatment complete without issue.During the return of blood from the circuit to the patient a leak was noted on the venous (blue) port of the hd catheter where the blue hub sits inside clear rubber tubing.Surgery was consulted and repaired the line.The line has been originally inserted approximately 4 months earlier.Point of leakage may be due to catheter bending at the site due to patient's habitus.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.Attempts to obtain additional information regarding the incident and device were unsuccessful.The device involved in the incident is a short term hemodialysis catheter.The instructions for use contain the following information."this catheter is indicated for a duration less than (30) days." the report stated the catheter was inserted approximately 4 months earlier.This is an off label use of the device.The report also indicated the line was repaired.This device does not have a repair kit.The report also stated that the "point of leakage may be due to catheter bending at that site due to patient's habitus".Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.The failure may be due to off label use or it may be patient related.

• Brand Name: 11.5F X 20CM DUO-FLOW CATHETER
• Common Device Name: SHORT TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7502054
• Report Number: 2518902-2018-00032
• Device Sequence Number: 1718965
• Product Code: MSD
• UDI-Device Identifier: 00884908026443
• UDI-Public: 884908026443
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K842416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018
• Report Date (Section F): 04/01/2018

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: 03/31/2018
• Device Model Number: MCDLT4400
• Device Catalogue Number: MCDLT4400
• Device Lot Number: MBYW290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 10/17/2018
• 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 Weight: 51
• Date Report Sent to FDA: 04/01/2018