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

Catalog Number	65SP035
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: (b)(6) 2017.Pma/510(k) number: k944178 and k083641.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.
Event or Problem Description
It was reported that a portex® bivona® aire-cuf® neonatal and pediatric tracheostomy tube air in the cuff decreased to half-capacity 6 hours after initial use with a patient.The issue was observed by medical personnel.It was unknown if the tube had been checked prior to use.The tracheostomy tube was replaced with a new one.No patient injury was reported.
Additional Manufacturer Narrative
One bivona® 3.5mm aire-cuf® neonatal and pediatric tracheostomy tube was returned for investigation.During functional testing, a syringe was used to inflate the device cuff and inflation balloon with 5cc's of air and the device was submerged under water; the device was manipulated while under the water.No bubbles (indicating a leak) were found escaping from the device.The cuff was removed from the water and the device cuff was inflated with 5cc's of air and allowed to sit for 4 hours.A loss of volume of the cuff was observed; however, a leak could not be detected.Investigation was unable to determine the root cause of the reported issue; however, no evidence was found to suggest a manufacturing defect.

• Brand Name: PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC 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: 6439277
• Report Number: 3012307300-2017-00767
• Device Sequence Number: 501006
• Product Code: JOH
• UDI-Device Identifier: 15021312000290
• UDI-Public: 15021312000290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2017

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: 65SP035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1