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

Model Number TC-xxxxx

Device Problems Loose or Intermittent Connection (1371); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2019

Event Type  malfunction  

Event Description

Defective chest tube: size 32 sorin group chest tube.Chest tube not marked with manufacturer name or size of the chest tube as it should be.The drainage holes in the chest tube were not completely punched through.This leaves possibility for one of the plastic pieces to become loose inside the patient.Chest tube removed immediately after placement and replaced with a new, non-defective chest tube.No injury to patient.

• Brand Name: SORIN GROUP CHEST TUBE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L / LIVANOVA USA, INC
• MDR Report Key: 8381701
• MDR Text Key: 137559764
• Report Number: MW5084514
• 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

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: TC-xxxxx
• Device Lot Number: 1823300052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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