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

Catalog Number	67HA80
Medical Device Problem Codes	Leak/Splash (1354); Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that three days following insertion of a smiths medical portex® bivona® adult tts¿ hyperflex¿ tracheostomy tube a cuff leak was noted.The patient's family noted that there was no air leak present upon tracheostomy (trach) tube change out.The family also speculated that the cuff membrane may have become thinner or that the material has changed.The tube was required to be changed out with no reported adverse effects.

• Brand Name: PORTEX® BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7806001
• Report Number: 3012307300-2018-03321
• Device Sequence Number: 1468972
• 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
• Report Date (Section B): 08/22/2018

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: 06/19/2022
• Device Catalogue Number: 67HA80
• Device Lot Number: 3418061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/22/2018
• 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