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

Model Number	67SP040
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-test the cuff was not inflating fully.No patient injury was reported.
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 and functional testing were performed.Sample was filled with 5cc of air in order to see if there was any functional problem.When the unit was inflated with air, the cuff only inflated one side.The cuff was manipulated; however, the cuff was not fully inflated.The failure was confirmed.A corrective and preventive actions(capa) was open to investigate this failure.The solution to be implemented will be to enhance the existing manufacturing teflon application process to reduce process variation to ensure teflon is fully distributed between the cuff and shaft interface.The most likely root causes identified during the capa investigations were: - inconsistency in the application and associated work instruction for the teflon process and means to confirm coverage on cuff and shaft.Including drying time and method.- inconsistency of cuff installation, including acetone drying time, cuff installation (stretch/expansion tool) rtv placement and rtv cleaning.- symmetry effects of wall thickness variation from the gum rubber process extruded cuffs - vague/unclear written work instructions - vague/unclear design controls - cuff wall thickness, ie cuff symmetry sensitivity as a function of cuff wall thickness.- unclear specifications for teflon amounts/coverage on cuff and shaft.- unclear cuff to shaft re-adhesion as a function of process controls and post processing conditions such as sterilization, environmental conditioning, shipping/distribution and shelf life.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: 15417196
• Report Number: 3012307300-2022-19080
• Device Sequence Number: 2620750
• Product Code: JOH
• UDI-Device Identifier: 15021312000726
• UDI-Public: 15021312000726
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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: 10/01/2024
• Device Model Number: 67SP040
• Device Catalogue Number: 67SP040
• Device Lot Number: 3880706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown