MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND PEDIATRIC NEONATAL TRACHEOSTROMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67NFPS35
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Codes	Hypoventilation (1916); Respiratory Distress Syndrome of Newborns (2046)
Date of Event	11/04/2022
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.No product information has been provided to date.
Event or Problem Description
It was reported that the patient was due for weekly trach change.Patient has a 3.5 trach tube cuffed with 2ml of sterile water.An hour after trach change, patient was eventing with increased c02s, restricted volumes on vent and giant air leak with head bobbing and retractions.Respiratory therapist (rt) at bedside with registered nurse (rn) troubleshooting cause of events and increasing c02.Changed trach out emergently with rt; previous trach cuff was found to not inflate.(unknown lot number).
Additional Manufacturer Narrative
Other, other text: no lot number was provided; therefore, device history record review could not be completed.One sample was received.No defects was found during visual inspection.No leak was found during fictional testing.The complaint was not confirmed.The root cause of the reported issue was not able to be determined.No corrective actions were taken since the complaint was not confirmed.

• Brand Name: BIVONA FLEXTEND PEDIATRIC NEONATAL TRACHEOSTROMY
• 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: 15793632
• Report Number: 3012307300-2022-27110
• Device Sequence Number: 11950558
• Product Code: JOH
• UDI-Device Identifier: 10351688518798
• UDI-Public: 10351688518798
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• 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): 02/17/2023

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: 67NFPS35
• Device Catalogue Number: 67NFPS35
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 02/16/2023
• 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