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.There was no harm to the patient.
Additional Manufacturer Narrative
Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.The device was compared to the template and all the correct components were used.Visual inspection of the device identified that the transition from the distal cuff band to the shaft was not as gradual as feasibly possible, but was within normal expectations.Cuff bands are always raised from the shaft and create a slight bump.The height will vary from device to device due to acceptable tolerance in cuff band thickness and the operator's judgement / technique in applying and smoothing adhesive.Without a good sample (i.E., a device that does not cause irritation with the end user) to compare to the bad sample, the investigation could not identify the true root cause.Since the investigation did not identify a manufacturing defect, no corrective actions are planned at this time.Update: h3, h6, h10.
Additional Manufacturer Narrative
Other, other text: no product was returned for evaluation.If product is received the investigation will be reopened.Dhr review was done, no issues related to the original complaint were found.

• 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): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13506204
• Report Number: 3012307300-2022-03114
• Device Sequence Number: 4073672
• 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,Followup,Followup
• Report Date (Section B): 03/15/2023

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
• 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
• Supplement Date Received by Manufacturer: 04/13/2022; 01/13/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 05/10/2022; 03/14/2023
• 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: Unknown