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

Model Number	75FHXL80
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a smiths medical portex® bivona® hyperflex¿ tracheostomy tube was reported to not be holding volume.Air was added and yet again was not holding air.After 10 minutes of being in use, a trach tube change out was performed.There were no reported adverse effects.

• Brand Name: PORTEX BIVONA HYPERFLEX TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• MDR Report Key: 9788659
• Report Number: 3012307300-2020-01766
• Device Sequence Number: 14096794
• Product Code: JOH
• UDI-Device Identifier: 15021312015690
• UDI-Public: 15021312015690
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081440
• 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
• Report Date (Section B): 03/04/2020

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 Model Number: 75FHXL80
• Device Catalogue Number: 75FHXL80
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/04/2020
• 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