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

Catalog Number	7551707
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported three tracheotomy cannulas with the same lot number presented an issue where the balloons would deflate approximately 7 to 20 days after use.The nurse sometimes needed to re- inflate every hour.There were no reported consequences to health observed for the patient.Only discomfort for the patient was noted.
Additional Manufacturer Narrative
Evaluation summary: visual inspection of the returned device was performed by the unaided eye under normal plant lighting and did not reveal any anomalies.Using a standard syringe, 20 ml of air was inserted into the inflation line; the cuff fully inflated.Following work instruction, (b)(4), the device was leak tested and no leaks were observed.The instruction for use, (b)(4) , states: "4.3 use either minimal leak or minimal occlusive volume techniques to establish the cuff and to ensure correct inflation at regular intervals".Silicone cuffs are permeable to air and therefore, subject to slow, spontaneous deflation and require monitoring at regular intervals.The cuffs are not designed to hold air for 7 to 20 days without adjustment.Lot 3178731 for 17 units was released for distribution on 25-apr-2016; there were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the dhr.Based on these results, this investigation did not confirm the complaint or reveal any intrinsic manufacturing defects with the returned device.No corrective actions are planned at this time.Smiths medical regularly analyzes complaint data and trends, and will take further actions accordingly.

• Brand Name: BIVONA 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: 7626556
• Report Number: 3012307300-2018-02485
• Device Sequence Number: 178580
• Product Code: JOH
• UDI-Device Identifier: 15021312006476
• UDI-Public: 15021312006476
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K914088
• 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,Followup
• Report Date (Section B): 08/28/2018

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: Nurse
• Device Expiration Date: 04/07/2021
• Device Catalogue Number: 7551707
• Device Lot Number: 3178731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1