MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC BIVONA® AIRE-CUF® PEDIATRIC STRAIGHT NECK FLANGE 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	01/17/2017
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.
Event or Problem Description
It was reported that the bivona® aire-cuf® pediatric straight neck flange tracheostomy tube had a leak in the device cuff.The event was observed spontaneously by a medical professional and the device was replaced after discovery.According to the reporter, the device was in patient use from (b)(6) 2017.The reported event occurred during the initial use of the tracheostomy tube and the device cuff was tested prior to patient use.It was reported that the event was resolved and that no patient injury occurred.
Additional Manufacturer Narrative
One bivona® 3.5mm aire-cuf® pediatric straight neck flange tracheostomy tube was returned for investigation.Visual inspection of the returned device was performed with the unaided eye and under normal plant lighting; no obvious defect was observed with the device.During functional testing, the device cuff was inflated with air and the device was submerged under water.No bubbles (indicating a leak) were found escaping from the device.Investigation determined that the returned device functioned as intended and no fault was found.

• Brand Name: BIVONA® AIRE-CUF® PEDIATRIC STRAIGHT NECK FLANGE 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: 6341315
• Report Number: 3012307300-2017-00479
• Device Sequence Number: 19053968
• Product Code: JOH
• UDI-Device Identifier: 15021312000290
• UDI-Public: 15021312000290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914088
• 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): 03/17/2017

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 Expiration Date: 07/25/2021
• Device Catalogue Number: 65SP035
• Device Lot Number: 3252576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 03/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1