MAUDE Adverse Event Report: MEDCOMP 11.5FX20CM HEMO-CATH; HEMODIALYSIS CATHETER

Model Number SLD11/20

Device Problems Air Leak (1008); Hole In Material (1293); Leak/Splash (1354)

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

Event Date 03/29/2010

Event Type  malfunction  

Event Description

It was reported that the catheter was inserted into the patient and then connected to aquarius set and machine.It was then noticed that air was going into the circuit and blood coming out of return leg of catheter.A small hole was noted in the tube.

Manufacturer Narrative

The device sample was returned for evaluation.A functional examination of the catheter revealed that the venous extension leaked from a hole 3.7 cm from the hub.Upon closer examination under magnification, the area of the leak was found to be a small cut.The extension was cross sectioned and measured.All measurements were within the dimensional specifications.This product family is 100% leak tested at the completion of the manufacturing process.There is no evidence of a manufacturing defect.We are unable to determine the exact cause of the incident; however it appears that the extension came into contact with a sharp edge.

• Brand Name: 11.5FX20CM HEMO-CATH
• 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 ; 2152564201
• MDR Report Key: 4554567
• MDR Text Key: 5523422
• Report Number: 2518902-2015-00011
• 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: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: SLD11/20
• Device Catalogue Number: SLD11/20
• Device Lot Number: MAWD570
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/02/2010
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2009
• 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