MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX; BIVONA TRACHEOSTOMY TUBE

Model Number 67HA80

Device Problems Device Operates Differently Than Expected (2913); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem No Information (3190)

Event Date 08/29/2017

Event Type  Injury  

Event Description

Portex bivona silicone tracheostomy tube product number 67ha80 does not have instructions for use either on or inside package.Specifically it is not identified that cuff must be inflated with sterile water.The vast majority of cuffs are inflated with air.This resulted in multiple care givers not being able to identify leaks around the cuff as it was originally inflated with air.

• Brand Name: PORTEX
• Type of Device: BIVONA TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL; gary IN 46406
• MDR Report Key: 6848236
• MDR Text Key: 85350401
• Report Number: MW5071994
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: 67HA80
• Device Lot Number: 2543719
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 82