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

Model Number	FT18JN40NSE055N
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
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 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 tracheostomy tube with tts cuff was returned for analysis.Visual inspection revealed that the cuff was torn.It was noted to be 2mm across and 9mm in length.The investigation did not reveal a manufacturing defects.Based on the evidence, the complaint was confirmed.However, the root cause is unknown.

• Brand Name: BIVONA CUSTOM 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: 8162899
• Report Number: 3012307300-2018-08741
• Device Sequence Number: 19256800
• Product Code: JOH
• UDI-Device Identifier: 15019517167894
• UDI-Public: 15019517167894
• 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): 01/16/2019

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: FT18JN40NSE055N
• Device Catalogue Number: FT18JN40NSE055N
• 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: 12/18/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/16/2019
• 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