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

Model Number	67P045
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while preparing to do a routine tracheostomy tube change, the balloon was not inflating fully when checked prior to tube change.There were no visible signs of tears or leaks when balloon was inflated but "it didn't look right".Two trachs were observed to have this issue from the same lot number.A third trach was used without issue.
Additional Manufacturer Narrative
Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The two used returned samples received and were inflated with air using a 5 ml syringe, after that the cuffs were gently manipulated.The whole cuff was inflated without abnormalities.It was demonstrated that the 2 cuffs were symmetrical, and no visible signs of tears or leaks were detected.Complaint is not confirmed.No root cause was determined due complaint was not confirmed.No corrective actions required since the complaint was not confirmed.D5 is unknown, no information provided to date.

• 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: 14944432
• Report Number: 3012307300-2022-13013
• Device Sequence Number: 6230958
• Product Code: JOH
• UDI-Device Identifier: 15021312006285
• UDI-Public: 15021312006285
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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: Lay User/Patient
• Device Expiration Date: 04/17/2025
• Device Model Number: 67P045
• Device Catalogue Number: 67P045
• Device Lot Number: 3959301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2020
• 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