MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	ST16GN90NSC105N
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	Apnea (1720)
Date of Event	07/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cuff of a portex® bivona® custom tracheostomy tube was asymmetrical.The patient's ventilator went into apnea mode due to the leak, and an emergency tracheostomy tube change was performed.No permanent injury was reported.
Additional Manufacturer Narrative
A portex® bivona® custom tracheostomy tube was returned for analysis.Visual inspection revealed no defects.Functional testing involved leak testing and showed no leaks.A review of the design history records confirmed that cuff symmetry met manufacturing acceptance criteria.The fault could not be confirmed.

• Brand Name: PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6966328
• Report Number: 3012307300-2017-02282
• Device Sequence Number: 1221870
• Product Code: JOH
• UDI-Device Identifier: 15019517064698
• UDI-Public: 15019517064698
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 02/17/2022
• Device Catalogue Number: ST16GN90NSC105N
• Device Lot Number: DS002503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention