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

Model Number	67PFS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: 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 an oxygen-dependent patient with complete atrioventricular canal with unfavorable evolution after surgery on (b)(6) 2023 has been ventilated on a tracheostomy cannula since (b)(6) 2023.When changing the cannula, the professionals have difficulty with the balloon, which does not inflate in a consistent manner.There was delayed resumption of ventilation, with deep desaturation (17%) and bradycardia at 80bpm.Change of cannula from the same batch, which inflates better.Professionals did not massage the balloon before attempting inflation with ppi water.The outcome of the event was resolved.A second cannula was documented on (b)(4).
Additional Manufacturer Narrative
Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Two devices were received without the original packaging.Per visual inspection, no visual defects were found.The complaint was not confirmed.No other analysis was performed.No root cause could be determined since the complaint was not confirmed, the returned devices do not show the failure mode reported, the units work as expected, no failure identified.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue will be monitored, and further actions taken accordingly.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17368460
• Report Number: 3012307300-2023-07492
• Device Sequence Number: 6978474
• Product Code: JOH
• UDI-Device Identifier: 10351688518606
• UDI-Public: 10351688518606
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K923878
• 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): 10/26/2023

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: 10/18/2024
• Device Model Number: 67PFS30
• Device Catalogue Number: 67PFS30
• Device Lot Number: 3884244
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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
• Patient Sex: Unknown