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

Model Number	FT19LN60NGA888N
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to smiths medical.The product was subject to a leak test after being inflated with air and was confirmed to exhibit a leak originating from the middle of the posterior side of the cuff.The product was subject to a leak test after being inflated with air and was confirmed to exhibit a leak originating from the middle of the posterior side of the cuff.It is not possible to determine the root cause with confidence.Dhr: there were no instances of rework, nonconformities, or discrepancies noted that were relevant to the complainant's issue.
Event or Problem Description
It was reported that a patient's mother inserted new trach and after one hour, the son stated that the cuff felt deflated.Mother inflated the cuff and after another hour the same issue happened.Mother then took out and tested two new trachs and both of them were not inflating.Mother had not thrown away the old trach that was taken out and reprocessed it to use on son.No patient injury was reported.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13514665
• Report Number: 3012307300-2022-03214
• Device Sequence Number: 5312375
• Product Code: JOH
• UDI-Device Identifier: 15019517215823
• UDI-Public: 15019517215823
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: Lay User/Patient
• Device Expiration Date: 04/20/2026
• Device Model Number: FT19LN60NGA888N
• Device Catalogue Number: FT19LN60NGA888N
• Device Lot Number: ST004052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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