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

Model Number MCDLT4400

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.Additional information has been requested regarding the incident.

Event 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.

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
• Type of Device: SHORT TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7502054
• MDR Text Key: 108277389
• Report Number: 2518902-2018-00032
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908026443
• UDI-Public: 884908026443
• Combination Product (y/n): N
• PMA/PMN Number: K842416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/01/2018,10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 04/01/2018
• Distributor Facility Aware Date: 03/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2018
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 51