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

Model Number	FT21DN40NGA062S
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The product is irritating the patients trachea causing a cough each time it was put in.Once overnight, the next was for about 30 mins - 1hr.There was no harm to the patient.
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 was received for evaluation.Visual inspection was performed.Visual inspection identified that the transition from the distal cuff band to the shaft was not as gradual as feasibly possible, but was within normal expectations.Without a good sample (i.E., a device that does not cause irritation with the end user) to compare to the received complaint sample, the investigation could not identify the true root cause - only a hypothesis that the end user is sensitive to variation in the cuff band height and/or the cuff band transition to the shaft.If the end user concurs that hypothesis is correct, a revised template specifying minimal adhesive application to the cuff bands can be submitted and a note entered in the custom lab ordering system to alert the operators and inspectors of the end user's request.Since the investigation did not identify a manufacturing defect, no corrective actions are planned at this time.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.

• Brand Name: BIVONA TUBES CUSTOM
• 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; 1201 commerce street; minneapolis, MN 55442
• MDR Report Key: 15195684
• Report Number: 3012307300-2022-15108
• Device Sequence Number: 20328063
• Product Code: JOH
• UDI-Device Identifier: 15019517264784
• UDI-Public: 15019517264784
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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: 08/25/2026
• Device Model Number: FT21DN40NGA062S
• Device Catalogue Number: FT21DN40NGA062S
• Device Lot Number: GA020756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female