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

Model Number	67N035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485)
Date of Event	09/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that a pediatric tracheostomy was in place but the balloon did not properly inflate.The patient had significant respiratory distress and high c02, due to poor ventilation.To find a functioning tracheostomy balloon, 2 (two) other tracheostomies were tested but reportedly failed.Additional information was received via customer email 20-oct-2022: the awareness date was amended.
Additional Manufacturer Narrative
H10: no lot number was provided; therefore, device history record review could not be performed.A photo and two product samples were received for evaluation.Visual and functional testing was performed.Visual inspection found no damaged could be detected.Functional testing found the cuff inflated successfully for two samples; the complaint was not confirmed.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA NEO/PED 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; rm. a-100, mc1111; minneapolis, MN 55442
• MDR Report Key: 15679595
• Report Number: 3012307300-2022-26335
• Device Sequence Number: 6407168
• Product Code: JOH
• UDI-Device Identifier: 15021312006223
• UDI-Public: 15021312006223
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2023

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: 67N035
• Device Catalogue Number: 67N035
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 03/14/2023; 06/16/2023
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 04/01/2023; 06/21/2023
• 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