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

Device Problem Defective Component (2292)

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

Event Date 02/16/2019

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC/ SORIN GROUP ITALIA S.R.L
• MDR Report Key: 8381710
• MDR Text Key: 137575764
• Report Number: MW5084515
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622105975
• UDI-Public: (01)00803622105975(240)TC-10132
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: TC-xxxxx
• Device Lot Number: 1833100059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 98