MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® BIVONA TTS CUSTOMIZED TRACHEOSTOMY (TRACH) TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	ST15AN50NSA138N
Medical Device Problem Codes	Material Discolored (1170); Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a cuff to a smiths medical portex® bivona tts customized tracheostomy (trach) tube was noted to be leaking.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One bivona tts customized tracheostomy (trach) tube was returned for analysis.Upon visual examination the tube was observed to be discolored; orange/brown substance to the inside of airway tubing and inflation balloon.No holes, cuts, tears or other defects were noted.No leak was observed in the airway inflation line or balloon cuff upon testing for leak.However, while the cuff was observed, the cuff was noted to be slightly asymmetrical.Based on the evidence, the device met all manufacturing specifications as the complaint was not confirmed.

• Brand Name: PORTEX® BIVONA TTS CUSTOMIZED TRACHEOSTOMY (TRACH) TUBE
• 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: 8202392
• Report Number: 3012307300-2018-09024
• Device Sequence Number: 263998
• Product Code: JOH
• UDI-Device Identifier: 10351688844750
• UDI-Public: 10351688844750
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/19/2020
• Device Catalogue Number: ST15AN50NSA138N
• Device Lot Number: CS025473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 61