MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	67P040
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/28/2022
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 trach changed from uncuffed to the cuffed.Post trach change patient had been less stable that shift.Had issues with ongoing intermittent leak post trach change to the cuffed trach and ongoing worsening ventilation status.Trach changed and upon inspection after removal, cuff found to be unevenly inflated.Cuff remained full attached full length on one side of trach tube.Rrt had put 5 ml of sterile water into cuff pre- trach change and cuff appeared to fully inflate but states did not appreciate that the cuff was not detached on the one spot.The level of harm was minimal harm.The impact of incident was ventilation and oxygenation and wob (work of breathing) all potentially negatively impacted due to ineffective cuff seal and caused the requirement for an additional trach change.
Additional Manufacturer Narrative
Device evaluated by manufacturer and h6.Health impact, event problem and evaluation codes: updated.One sample was received for investigation without its original packaging.Visual inspection was performed at a distance of 12 inches and normal conditions of illumination to detect any damage on the cuff, airline or pilot balloon.No damage could be detected.A leak test was performed under water.Cuff inflated successfully no leaks were detected; the complaint was not confirmed.A device history record (dhr) review noted there were no issues or non-conformances reported during the manufacture of this lot.No corrective actions were taken since the complaint was not confirmed.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 16124452
• Report Number: 3012307300-2023-00273
• Device Sequence Number: 8490084
• Product Code: JOH
• UDI-Device Identifier: 15021312006278
• UDI-Public: 15021312006278
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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 Expiration Date: 02/16/2024
• Device Model Number: 67P040
• Device Catalogue Number: 67P040
• Device Lot Number: 3763993
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 04/02/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2019
• 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