MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA® CUSTOMIZED 4.5MM TTS¿ FLEXTEND¿ TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	XT15AS45NGA116S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One bivona® customized tts¿ hyperflex¿ tracheostomy tube was returned for investigation.During functional testing, the device was submerged in water and the cuff was inflated with 5cc of air.A leak was found in the pilot balloon.The device pilot balloon was then inspected under magnification and three cuts were observed.The observed cuts were found to be consistent with the teeth marks; however, investigation could not determine a definitive root cause.
Event or Problem Description
It was reported that after the first day of placement of the bivona® customized 4.5mm tts¿ flextend¿ tracheostomy tube, the nurse observed a leak in the device cuff and the cuff would not remain inflated.According to the report, it was observed that water was leaking from the cuff.After the leak was noted, the device was replaced and the event was resolved.The reported issue occurred during the initial use of the device and the device cuff was filled with sterile water.It was reported that no patient injury occurred and that no medical treatment was provided due to the reported event.

• Brand Name: BIVONA® CUSTOMIZED 4.5MM TTS¿ FLEXTEND¿ 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: 6415263
• Report Number: 3012307300-2017-00681
• Device Sequence Number: 11038582
• Product Code: JOH
• UDI-Device Identifier: 10351688849946
• UDI-Public: 10351688849946
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2017

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: Health Professional
• Device Expiration Date: 01/17/2022
• Device Catalogue Number: XT15AS45NGA116S
• Device Lot Number: DS000751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 17