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

Model Number 75HA80

Device Problem Leak/Splash (1354)

Patient Problem Decreased Respiratory Rate (2485)

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 307585761
• Report Number: 3012307300-2023-00535
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312013856
• UDI-Public: 15021312013856
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K081440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/26/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 03/11/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention