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

Model Number 100/800/075

Device Problem Inflation Problem (1310)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

No device was returned for investigation.

Event Description

It was reported that while in use, the medical staff found that the air bag can not be used.This was during a trach surgery while inserting the trach catheter.The air bag was removed to check the damage which caused serious injury to the patient.A new bag was immediately used to finish the procedure.

Manufacturer Narrative

Other text: h10 correction: incorrect item number previously submitted, also added manufacture date and expiration date of lot of the correct item number.Updated udi information.No product returned.

• Brand Name: PORTEX CUFFED BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• 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; tongzhou sub-district office; minneapolis, MN 55442
• MDR Report Key: 12979300
• MDR Text Key: 282092928
• Report Number: 3012307300-2021-12637
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100/800/075
• Device Catalogue Number: 100/800/075CZ
• Device Lot Number: 3933129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male