MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBES WITH SUCTIONAID®; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/870/070

Device Problem Leak/Splash (1354)

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

Event Date 06/01/2018

Event Type  Injury  

Event Description

Information was received that during the use of a smiths medical portex tracheostomy, air was leaking from the cuff.As a result, a trach change out was required.No patient adverse events were experienced.

Manufacturer Narrative

Device evaluation: one portex suctionaid sample was received in used condition without the original packaging immediate visual inspection detected no issues.A leak test was performed via syringe and a cuff leak was found in the sample.The complete manufacturing process of inflation tests was audited during thirty two (32) units, finding no discrepancies and samples were 100% leak tested.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and testing, the complaint allegation was confirmed.The problem source for this specific event was stated as unknown.As a preventive action, manufacturing personnel were notified by the supervisor and quality engineer about failure mode reported by the customer.

• Brand Name: PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBES WITH SUCTIONAID®
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7687398
• MDR Text Key: 114001725
• Report Number: 3012307300-2018-02698
• Device Sequence Number: 1
• Product Code: BTO
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 100/870/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Date Manufacturer Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention