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

Catalog Number	65P045
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that an air-leak was noted to a smiths medical bivona® aire-cuf® tracheostomy tube after placement.Subsequently, it was required that an "emergent tracheostomy change out" was performed.The patient had been previously transferred to the intensive care unit for deteriorating respiratory status requiring the previous tracheostomy to be changed to the smiths product.Upon filling the cuff with air, an air-leak was noted, making the cuff's air pressure zero.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One used bivona® aire-cuf® tracheostomy tube was received for investigation.A visual inspection was performed and no damage to the cuff or tube could be detected.The unit was inflated and visually inspected and there was no leakage, and the cuff was noted as being "well inflated".A manufacturing review was performed and no discrepancies were found.The complaint was not confirmed.

• Brand Name: 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: 6965718
• Report Number: 3012307300-2017-02274
• Device Sequence Number: 18974113
• Product Code: JOH
• UDI-Device Identifier: 15021312005981
• UDI-Public: 15021312005981
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 65P045
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 03/15/2018
• 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