MAUDE Adverse Event Report: SMITHS MEDICAL ASD SMITHS MEDICAL PORTEX TUBES BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 100/800/060CZ

Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  Injury  

Event Description

Information was received that a smiths medical - portex tubes blue line ultra tracheostomy could not pass air through the cannula.Another cannula was tried, however the issue persisted.When the cannula was changed yet again, the cannula functioned properly.The patient was unable to breath normally through the cannulas.It was also reported that the cugg was not working correctly, and xylocain 2% gel was used.It was thought to have melted the product.No patient injury occurred as a result.

Manufacturer Narrative

Two blue line ultra tracheostomy tubes were returned for analysis in good condition.Under visual inspection there was no noted occlusion within the cannula.Inflation testing was performed indicating one cuff could not inflate due to a cuff tear and the second was found fully inflated after 12 hours.Based on the evidence, the complaint was confirmed with the root cause being user interface.

• Brand Name: SMITHS MEDICAL PORTEX TUBES BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; 201 west queen street; southington CT 06489
• MDR Report Key: 8965932
• MDR Text Key: 156631006
• Report Number: 3012307300-2019-04724
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 100/800/060CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention