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

Model Number	FT18AN45NGF932N
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff was inflating asymmetrically.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.During investigation the cuff was inflated with 6cc of air, per inspection procedure.Upon an initial visual examination of the trach it is evident that the cuff does have a slight degree of asymmetry, however it was confirmed to be within manufacturing tolerance.In reference to the manufacturing work instruction it states, measurements should be taken at the most asymmetric orientation, and in regard to the dimensions it states.The larger value must not exceed the small value by more than 2x.In this case the investigation results verify the cuff measurements to be 11mm and 9mm, pictures attached.These values pass our quality spec parameters, no function errors were found after examining this device.Based on these findings, there is no fault found with the returned device, and therefore no corrective actions are deemed necessary at this time.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15445244
• Report Number: 3012307300-2022-19597
• Device Sequence Number: 20715401
• Product Code: JOH
• UDI-Device Identifier: 15019517138313
• UDI-Public: 15019517138313
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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: 11/24/2024
• Device Model Number: FT18AN45NGF932N
• Device Catalogue Number: FT18AN45NGF932N
• Device Lot Number: SS025213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown