MAUDE Adverse Event Report: LIVANOVA USA, INC/ SORIN GROUP ITALIA S.R.L CHEST TUBE; CATHETER, CANNULA AND TUBING, VASCULAR CARDIOPULMONARY BYPASS

Model Number	TC-xxxxx
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Defective chest tube.Size 32 livanova/sorin group chest tube was not marked with company name or size of tube as per usual.Drainage holes in the chest tube were not completely punched through.This leaves the possibility for one of the plastic pieces that are not completely punched through to become loose inside the patient.Chest tube was removed immediately after placement and replaced with a new, non-defective chest tube.

• Brand Name: CHEST TUBE
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC/ SORIN GROUP ITALIA S.R.L
• MDR Report Key: 8381710
• Report Number: MW5084515
• Device Sequence Number: 13899234
• Product Code: DWF
• UDI-Device Identifier: 00803622105975
• UDI-Public: (01)00803622105975(240)TC-10132
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: TC-xxxxx
• Device Lot Number: 1833100059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 98