MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA NEO/PED TTS TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SN035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.
Event or Problem Description
It was reported that during a bedside exchange by the ent provider the balloon would not expand for the trach.The reported event was resolved by replacing with a different trach.There was no patient injury reported.
Additional Manufacturer Narrative
Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two (2) product samples were received for evaluation.Visual and functional testing was performed.Visual inspection found no discrepancies.Functional testing found the cuffs were inflated without abnormalities.It was demonstrated that the cuffs were symmetrical, and no leak was detected.Devices passed all functional testing.No problem found.Root cause cannot be determined as the samples were successfully tested.E4 is unknown, no information provided to date.

• Brand Name: BIVONA NEO/PED TTS TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY 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; minneapolis, MN 55442
• MDR Report Key: 13928090
• Report Number: 3012307300-2022-05370
• Device Sequence Number: 1790761
• Product Code: JOH
• UDI-Device Identifier: 15021312000252
• UDI-Public: 15021312000252
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083641
• 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,Followup
• Report Date (Section B): 11/10/2022

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: 05/20/2026
• Device Model Number: 67SN035
• Device Catalogue Number: 67SN035
• Device Lot Number: 4153588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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
• Patient Sex: Unknown