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

Model Number	670160
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Codes	Forced Expiratory Volume Decreased (2430); Decreased Respiratory Rate (2485)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device lot number is unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that the customer has had to change out several trach tubes due to them having leaks.When checked, after the trach change was completed, the cuffs were noted to have pin size holes in them.Causing the patient to loose volume while on the ventilator.No injury or adverse affects after trach change was completed.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two product samples were received for evaluation.Visual and functional testing were performed.During the visual inspection, holes were detected in both samples; therefore, leaks were detected for two samples.The root cause of the reported issue was found to be manufacturing.Actions were taken to mitigate the reported issue: a corrective and preventative action has been opened to address the reported issue.

• Brand Name: BIVONA SILICONE TRACHEOSTOMY TUBES
• 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15353086
• Report Number: 3012307300-2022-17573
• Device Sequence Number: 6192947
• Product Code: JOH
• UDI-Device Identifier: 15021312006032
• UDI-Public: 15021312006032
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K083641
• 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): 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 670160
• Device Catalogue Number: 670160
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown