MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT18DN45NSF031N
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: clinical resource manager.
Event or Problem Description
Information was received that a smiths medical bivona custom tts flextend tracheostomy tube cuff leaked while in use with a picu patient.Subsequently, respiratory was called to the bedside to perform an emergent tracheostomy (trach) change out.No adverse patient effects were reported.
Additional Manufacturer Narrative
One flextend tts tracheostomy (trach) tube was returned for analysis.No issues were found upon visual inspection.A leak test was performed; sample leaked at airway junction.Magnification was used to note a small pin hole in the adhesive where the airway inserts into the neck flange.Based on the evidence, the complaint was confirmed.The root cause was found to be from manufacturing as it is thought that a tiny air bubble in the adhesive may have popped due to manipulation or pulling of the airway line.

• Brand Name: BIVONA CUSTOM 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: 8162897
• Report Number: 3012307300-2018-08745
• Device Sequence Number: 11294219
• Product Code: JOH
• UDI-Device Identifier: 15019517146813
• UDI-Public: 15019517146813
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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 Model Number: FT18DN45NSF031N
• Device Catalogue Number: FT18DN45NSF031N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/24/2019
• 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: Life Threatening; Required Intervention