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

Catalog Number	ST19EN55NGG996N
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Extubate (2402); No Information (3190)
Date of Event	08/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the stopper on the pilot balloon of a smiths medical tracheostomy pops out.No adverse effects reported.
Additional Manufacturer Narrative
The tracheostomy tube needed to be changed to resolve the originally reported issue.Reportable information indicated that it should be changed to a serious injury.

• Brand Name: SMITHS MEDICAL SILICONE BIVONA CUSTOME 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: 9168551
• Report Number: 3012307300-2019-05529
• Device Sequence Number: 2591841
• Product Code: JOH
• UDI-Device Identifier: 15019517190663
• UDI-Public: 15019517190663
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: ST19EN55NGG996N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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: Required Intervention
• Patient Age: 12 YR