MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® PORTEX® BLUE LINE ULTRA® CUFFED TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 100/150/080

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/15/2019

Event Type  Injury  

Event Description

Information was received that during verification of the cuff of a smiths medical portex endotracheal tube, the manometer indicated "zero pressure" while the cuff appeared to be over inflated.This occurred once again on the second attempt.On the third test with a different manometer, it also indicated "zero pressure".While testing the third time, the user noted the tracheal tube had caused haemodynamic lability on leaks of forene solution, and the benchmark tracheal tube had slipped two centimeters.Immediately, patient was secured for repositioning of the tracheal tube and reintubation.The patient was then stabilized.

• Brand Name: PORTEX® PORTEX® BLUE LINE ULTRA® CUFFED TRACHEOSTOMY 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: 8906418
• MDR Text Key: 154739930
• Report Number: 3012307300-2019-04041
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 100/150/080
• Device Lot Number: 19022580
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MANOMETER- NON SMITHS MEDICAL DEVICE
• Patient Outcome(s): Required Intervention