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

Model Number	AT20FS35NGA035N
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One hyperflex device trach was returned for analysis.Upon arrival, the cuff was observed to be slightly inflated.A syringe was used to remove the contents of the cuff; failing to remove all contents.Air was then inserted into the inflation valve revealing that the balloon was significantly extended.Visual inspection confirmed that the teflon tubing was in place and inspection of the inflation lumen revealed that the lumen appeared to be bulging.The adjustable neck flange in relationship to the inflation lumen was inspected; noting that the lumen did not appear to be fully in line with the cutout section in the locking strap.The locking strap was then removed from the retaining pin, the cuff instantly inflated, and the inflation line and balloon deflated.Based on the evidence, the complaint was confirmed.The root cause was found due to user interface.
Event or Problem Description
Information was received indicating that upon removal of a smiths medical bivona customized tracheostomy tube, the cuff would not deflate.It was reported that all the water was removed from the cuff and pilot balloon and was difficult to remove.The trach tube was removed, and the cuff was still inflated.Another trach tube was placed with no reported adverse effects.

• Brand Name: BIVONA CUSTOMIZED 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: 10296280
• Report Number: 3012307300-2020-07421
• Device Sequence Number: 11473566
• Product Code: JOH
• UDI-Device Identifier: 15019517231922
• UDI-Public: 15019517231922
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• 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
• Report Date (Section B): 07/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AT20FS35NGA035N
• Device Catalogue Number: AT20FS35NGA035N
• Device Lot Number: BS007987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/20/2020
• 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