MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; Tube tracheostomy and tube cuff

Model Number	SZ20FN60NSZ007S
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes custom was leaking reported trachs are looking different than before and the cuffs are not holding water like they used to as for having to add more water and work harder to keep air out.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4) a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Product sample was received for evaluation.Visual and functional testing were performed.One device was returned for two complaints.The returned device determined that device did not match the provided part number or lot number.The returned device was assembled with white-colored silicone, which is used for standard product.Visual inspection confirmed a ruptured cuff, but it also confirmed that the product was beyond the 5-year shelf life stated on the labeling for the product.The instruction for use, stated under warnings to use either minimal leak or minimal occlusive volume techniques to establish the cuff and to ensure correct inflation at regular intervals.Under-inflation of the cuff may result in aspiration of subglottic secretions leading to lung infections.Over-inflation may result in permanent damage to the trachea.The root cause of the reported issue could not be confirmed.No corrective actions are planned at this time.The manufacture regularly analyzes complaint data and trends and will take further actions accordingly.

• 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: 11957312
• Report Number: 3012307300-2021-05709
• Device Sequence Number: 13776922
• Product Code: JOH
• UDI-Device Identifier: 15019517230871
• UDI-Public: 15019517230871
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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: 01/25/2026
• Device Model Number: SZ20FN60NSZ007S
• Device Catalogue Number: SZ20FN60NSZ007S
• Device Lot Number: GA014266
• 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: 05/07/2021
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown