MAUDE Adverse Event Report: MEDCOMP 14.5FX8CM PC HEMO-FLOW; HEMODIALYSIS CATHETER

Model Number HFS28PCE

Device Problems Air Leak (1008); Material Discolored (1170); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2014

Event Type  malfunction  

Event Description

During hemodialysis process air was noted in the catheter.After deep evaluation of catheter, small holes have been noticed in the area between access of catheter to patient's skin and triangle/split of blue and red lines.

Manufacturer Narrative

The device involved in the complaint was not returned for evaluation.Photographs of the device were provided.The photos showed a longitudinal tear in the lumen starting at the hub.The lumen material appears slightly swollen in the area of the tear.A review of the manufacturing records indicated all device specifications and quality requirements were satisfied.Without evaluating the device we are unable to determine the cause of factors which may have contributed to this event.The device was implanted for 8 months with no reported problems.

• Brand Name: 14.5FX8CM PC HEMO-FLOW
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; harleysville PA
• Manufacturer (Section G): MEDCOMP; 1499 delp dr.; harleysville PA 19438
• Manufacturer Contact: susan smith, rn ; 1499 delp dr.; harleysville, PA 19438 ; 2152564021
• MDR Report Key: 3912244
• MDR Text Key: 4668692
• Report Number: 2518902-2014-00035
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: HFS28PCE
• Device Catalogue Number: HFS28PCE
• Device Lot Number: MCYL510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2014
• Initial Date FDA Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention