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

Model Number	75HA80
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the trach tube was found leaking while it was put into an icu neuro patient.A trach change resolved the issue.
Additional Manufacturer Narrative
Date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Additional Manufacturer Narrative
Event methods, evaluation, and conclusion heic codes: updated.One device was received for investigation.Visual inspection of the returned device did not reveal any defects.The device was functionally tested using a syringe to inflate the device cuff, while manipulating the line and applying pressure to the cuff and balloon and shaft.The device passed the functional testing with no leakage or deflation detected.A review of manufacturing device history records for the reported lot number found no issues or non-conformances initiated for the lot.Based on the available information, the investigation could not reproduce or confirm the reported issue, and no root cause could be attributed.No actions have been taken at this time.

• Brand Name: BIVONA ADULT HYPERFLEX TRACHEOSTOMY TUBE
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; borivili east; minneapolis, MN 55442
• MDR Report Key: 16194841
• Report Number: 3012307300-2023-00535
• Device Sequence Number: 14901577
• Product Code: JOH
• UDI-Device Identifier: 15021312013856
• UDI-Public: 15021312013856
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 75HA80
• Device Catalogue Number: 75HA80
• Device Lot Number: 4265160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2022
• Supplement Date Received by Manufacturer: 03/11/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown