MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE

Model Number 100/860/080

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2021

Event Type  malfunction  

Event Description

During the use of the product, leakage of air from the pilot balloon was observed.No patient injury.

Manufacturer Narrative

Other, other text: additional information h.6: added method, result, and conclusion codes.Additional information h.10: device evaluation - one tracheostomy tube was received for evaluation in relation to the reported event.Functional testing of the device was able to confirm and replicate the reported event.The cuss was not able to stay inflated.Root cause was unable to be determined due to the nature of the reported event.A dhr review was unable to be completed as no lot information was provided.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 12980426
• MDR Text Key: 282099871
• Report Number: 3012307300-2021-12641
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/860/080
• Device Catalogue Number: 100/860/080
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 02/20/2022
• Supplement Dates FDA Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1