MAUDE Adverse Event Report: MEDCOMP 13.5FX15CM PSIL DBL LMN W/STYLE; HEMODIALYSIS CATHETER

Model Number SDL136E

Device Problem Air Leak (1008)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

Some air bubbles and bleeding appeared when using the internal right jugular catheter.Air bubbles in the tubing: there is a notch on the tubing, like it was cut.

Manufacturer Narrative

An investigation has been initiated.When the investigation is complete, a supplemental report will be submitted.

Manufacturer Narrative

The hole on the lumen is "v" shaped.A review of the manufacturing records indicated that all device specifications and quality requirements were satisfied.This device family is 100% leak tested at the end of the manufacturing process which would detect any failures.We are unable to determine the exact cause of the failure however it appears that the device came into contact with a sharp edge, such as a needle bevel at some point during a clinical procedure.There is no evidence of a manufacturing defect.

• Brand Name: 13.5FX15CM PSIL DBL LMN W/STYLE
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith, rn ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 4611736
• MDR Text Key: 5767248
• Report Number: 2518902-2015-00033
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/28/2018
• Device Model Number: SDL136E
• Device Catalogue Number: SDL136E
• Device Lot Number: MFWG730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• 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