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

Catalog Number 100/800/075CZ

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

Foreign: (b)(6).

Event Description

Information was received that the cuff of a smiths medical portex blue line ultra cuffed tracheostomy tube ruptured after pushing air during tube insertion.No adverse patient effects were reported.

Event Description

Additional information received stating patient injury did occur, but no medical intervention was required, and the incident has been resolved.

Manufacturer Narrative

One blue line ultra tracheostomy tube was returned for analysis in used condition.Under visual inspection the tube appeared to be in good condition.Inflation testing was performed and repeated observing that the cuff would not inflate.The sample was then submerged in water with a tear in the cuff (approximately 0.2mm); confirming the complaint.Based on the evidence, the most likely cause was due to user interface.

• Brand Name: PORTEX BLUE LINE ULTRA CUFFED TRACHEOSTOMY TUBE CUFF
• 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: 8688849
• MDR Text Key: 147651819
• Report Number: 3012307300-2019-03384
• 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,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 100/800/075CZ
• Device Lot Number: 3577893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 34