MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	65P050
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Additional 510k number - k083641.
Event or Problem Description
It was reported that during patient use of the bivona® aire-cuf® neonatal and pediatric tracheostomy tube, the device cuff had an air leak and was unable to remain inflated.The tracheostomy tube was replaced after the reported issue was observed.It is unknown how long the device was in patient use before the incident was observed.The device cuff patency was tested prior to patient use.The event was considered resolved.No permanent injury was reported.
Additional Manufacturer Narrative
One bivona® 5.0 mm aire-cuf® neonatal and pediatric tracheostomy tube was returned for investigation.Visual inspection revealed no defects or abnormalities with the returned device.During functional testing, the device cuff was inflated with air and the device was submerged under water.No bubbles (indicating a leak) were observed escaping from the device.Investigation was unable to confirm the reported event and found that the device functioned as intended.

• Brand Name: PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• 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: 6523370
• Report Number: 3012307300-2017-00898
• Device Sequence Number: 16267251
• Product Code: JOH
• UDI-Device Identifier: 15021312005998
• UDI-Public: 15021312005998
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 65P050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1