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

Model Number	7.0 MM
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reported a smiths medical tracheostomy|silicone - bivona tubes custom malfunctioned, causing a tracheotomy change.The event was described as a port on patient's trache had once again been pushed all the way in.When checking the water in the cuff, there was only 6.5ml, and the assumption of a potential leak occurred.A trache change was conducted.
Additional Manufacturer Narrative
Other, other text: one device was returned for analysis.The inflation valve was seated correctly.No cuts or tears were identified at the opening in the silicone balloon that would contribute to the valve not remaining seated.Note that the inflation valve is a press fit.Using a twisting motion when securing the syringe to the inflation valve may cause the value to move inside the balloon and allow water to leak.Using the syringe, the inflation valve may be returned to the correct position, which would stop the water from escaping.No leaks were detected.The device was inflated with 15 ml of water and allowed to rest for four hours.No leakage was observed.Using a syringe approximately 15 ml of water was removed form the device.Note it is impossible to remove exactly 15 ml of water due to a small amount of residuals that remain in the inflation system.No defects were identified with the device.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11697601
• Report Number: 3012307300-2021-03319
• Device Sequence Number: 14311827
• Product Code: JOH
• UDI-Device Identifier: 15019517150933
• UDI-Public: 15019517150933
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 07/20/2025
• Device Model Number: 7.0 MM
• Device Catalogue Number: HT18ES70NSZ003N
• Device Lot Number: BS008677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1