MAUDE Adverse Event Report: MEDCOMP 14.5FX24CM HEMO-FLOW; HEMODIALYSIS CATHETER

Model Number HFS24E

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Date 05/08/2015

Event Type  malfunction  

Event Description

In the past 4 weeks we have had 5 of these catheters prematurely fall out and 2 have partially come out.All catheters have come out within 4-6 weeks of insertion.All catheters have been inserted by regular doctors.There have been no changes to practice.It appears the cuffs have not adhered internally to the patient tissue.Other patients have had the same batch of lines inserted with no reported problems.However the batch number has not been retained on the patients whose lines have come out.

Manufacturer Narrative

The device involved in the incident was not returned for evaluation.A review of the manufacturing records indicated that all device specifications and quality requirements were satisfied.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 14.5FX24CM 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 ; 1499 delp dr.; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 4850053
• MDR Text Key: 5868158
• Report Number: 2518902-2015-00056
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• 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: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: HFS24E
• Device Catalogue Number: HFS24E
• Device Lot Number: MGGT700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention