MAUDE Adverse Event Report: MEDCOMP 13.F X 24 CM DIL DBL LMN W/STYLE; HEMODIALYSIS CATHETER

Model Number SDL139E

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

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

Event Date 03/20/2010

Event Type  malfunction  

Event Description

It was reported that there was fluid/blood leakage from the arterial extension.Hole in the silicone transparent part of the extension.

Manufacturer Narrative

One intact 13.5f x 24 cm silicone catheter was returned for evaluation.A functional examination of the catheter revealed a cut on the arterial extension 0.5 cm for the hub.The cut is 0.3 cm in length.A review of the manufacturing records indicated all device specifications and quality requirements were satisfied.This product family is 100% leak tested during the manufacturing process.We are unable to determine the cause or factors which may have contributed to this event; however there is no evidence of a manufacturing defect.

• Brand Name: 13.F X 24 CM DIL DBL LMN W/STYLE
• 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: 4554588
• MDR Text Key: 20073048
• Report Number: 2518902-2015-00012
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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 Model Number: SDL139E
• Device Catalogue Number: SDL139E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2010
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2010
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Weight: 80