MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA NON-ADJUSTABLE WIRED TRACHEOSTOMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT22AN35NSE977N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was asymmetrical filling of cuff on a custom trach for the patient.Discovered during testing.There was no patient injury reported.
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
Additional Manufacturer Narrative
Other, 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.Both devices were subjected to cuff symmetry testing.In each case, the cuffs were determined to meet the acceptance criteria.Based on these findings, this complaint issue could not be confirmed as a manufacturing issue, nor would these products be considered rejectable.No corrections or corrective actions are deemed necessary at this time.Root cause cannot be determined as the samples were successfully tested and no discrepancies were detected.

• Brand Name: BIVONA NON-ADJUSTABLE WIRED TRACHEOSTOMY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 13793118
• Report Number: 3012307300-2022-04622
• Device Sequence Number: 14429895
• Product Code: JOH
• UDI-Device Identifier: 15019517291582
• UDI-Public: 15019517291582
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: FT22AN35NSE977N
• Device Catalogue Number: FT22AN35NSE977N
• Device Lot Number: ST009971
• 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: 02/16/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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
• Patient Sex: Unknown