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

Catalog Number	67HA80
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical tracheostomy was unable to connect to ventilator at site between 15mm connector and tube.This resulted in an air leak, a ventilator alarm and a tracheostomy tube change out for the patient.No injury to the patient occurred.
Additional Manufacturer Narrative
One 8.0 tts adjustable hyperflex tracheostomy tube was returned for evaluation.Device underwent leak testing by applying air to the device.The occurrence of air bubbles coming from the junction of the plastic iso connector and silicone tube was not confirmed when the device was pressurized with air and aggressively manipulated while under water, thus not confirming the reported customer complaint.

• Brand Name: SMITHS MEDICAL BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿ TRACHEOSTOMY
• 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: 8596570
• Report Number: 3012307300-2019-02581
• Device Sequence Number: 16692379
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: 15021312013818
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 12/20/2022
• Device Catalogue Number: 67HA80
• Device Lot Number: 3540987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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