MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, CUSTOM; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	FT22AN40NSE140N
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer was experiencing trach tube cuff inflation issues.There was no injury to the patient or intervention required.The cuff was checked prior to usage or placement in patient, so no harm resulted.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample and an unknown device accompanied the sample was received for evaluation.Visual and functional testing were performed.Visual inspection of both samples found no anomalies were detected.Functional testing found there was a slight delay in the cuff inflating on the sample device, but it fully inflated without intervention.The cuff of the unknown device immediately inflated.Both devices were leak tested per work instruction.No leaks were detected.Root cause cannot be determined as the sample and unknown device were successfully tested and no discrepancies were detected.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, CUSTOM
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14644336
• Report Number: 3012307300-2022-11307
• Device Sequence Number: 5756778
• Product Code: JOH
• UDI-Device Identifier: 15019517293487
• UDI-Public: 15019517293487
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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 Model Number: FT22AN40NSE140N
• Device Catalogue Number: FT22AN40NSE140N
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/12/2022
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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