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

Model Number	FT15DN40NSE004N
Medical Device Problem Code	Leak/Splash (1354)
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 tracheostomy was returned for evaluation.Upon visual inspection, it was noted to have a broken cuff.During manufacturing, quality inspectors take a representative sample of the lot and performs leak tests on those devices.The most probable cause of issue has been determined to be that damage occurred after device left shm facility.

• 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: 8162896
• Report Number: 3012307300-2018-08744
• Device Sequence Number: 2120138
• Product Code: JOH
• UDI-Device Identifier: 10351688831880
• UDI-Public: 10351688831880
• 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): 04/02/2019

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: FT15DN40NSE004N
• Device Catalogue Number: FT15DN40NSE004N
• 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: 03/04/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 04/02/2019
• 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