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

Model Number 67P040

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/28/2022

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 306981795
• Report Number: 3012307300-2023-00273
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006278
• UDI-Public: 15021312006278
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 04/02/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention