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
One device was received for analysis.No anomalies could be detected on the returned sample neither were there any cuts or tears identified.Using a standard syringe, 15 ml of air was inserted into the inflation line.The cuff fully inflate.Per work instruction, (b)(4) rev 112, the device was leak tested.No leaks were detected.The device was inflated with 15 ml of water and allowed to rest for four hours.No leakage was observed.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11697618
• Report Number: 3012307300-2021-03320
• Device Sequence Number: 3436671
• 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): 06/15/2021

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?: No
• 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: 05/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/3021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1