MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® ENDOTRACHEAL TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 100/150/075

Device Problems Deflation Problem (1149); Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Event Description

It was reported that the cuff component of the portex® endotracheal tube was not deflating upon extubation.No death or serious injury was reported in connection with this incident.

Manufacturer Narrative

Corrected information: information was received that this issue may have occurred with more than one device, but could not confirm further details.The customer could not determine the total quantity of device(s) involved.

• Brand Name: PORTEX® ENDOTRACHEAL TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7789477
• MDR Text Key: 117328774
• Report Number: 3012307300-2018-03225
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/17/2022
• Device Catalogue Number: 100/150/075
• Device Lot Number: 17091775
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1