MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿ TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67HA80
Medical Device Problem Codes	Leak/Splash (1354); Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a portex® bivona® adult tts¿ adjustable neck flange hyperflex¿ tracheostomy tube did not have instructions for use either on or inside the device package.Specifically, it was not identified that the cuff must be inflated with sterile water.This resulted in caregivers not being able to identify leaks around the cuff as it was originally inflated with air.The event report type was reported as serious injury, and the event outcome as required intervention.No information regarding the type of injury or intervention required was provided.No permanent injury was reported.

• Brand Name: PORTEX® BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿ 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: 6945673
• Report Number: 3012307300-2017-02169
• Device Sequence Number: 13748932
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: 15021312013818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

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: 10/28/2018
• Device Catalogue Number: 67HA80
• Device Lot Number: 2543719
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/12/2017
• 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