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

Model Number	FT19IN40NGF043N
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 when water was added to the tracheostomy cuff, the entire plastic of the pilot balloon detached.The tracheostomy was used on the patient for two weeks.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Device evaluation: only one picture of a side view was submitted for investigation.Review of the picture showed that the inflation valve was not fully seated in the pilot balloon; it extended partially outside the pilot balloon.Since a picture of the opening (i.E., end view) where the inflation valve is inserted into the pilot balloon was not provided, the investigation could not confirm or deny that there was a short shot / void or a cut near the opening in the pilot balloon that would have allowed the valve to fall out of position.The side view did not identify any anomalies with the pilot balloon or the valve.Since there were no defects detected with the pilot balloon or inflation valve via the picture, it is likely that a twisting motion was used when inserting the syringe to the valve and the valve was dislodged from its position in the pilot balloon.No lot number was provided, therefor a device history report (dhr) review could not be completed.No product has been returned and the investigation could not confirm a manufacturing defect based on the picture.No corrective actions are planned at this time.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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: 16287511
• Report Number: 3012307300-2023-00834
• Device Sequence Number: 4929821
• Product Code: JOH
• UDI-Device Identifier: 15019517204247
• UDI-Public: 15019517204247
• 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): 07/21/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: FT19IN40NGF043N
• Device Catalogue Number: FT19IN40NGF043N
• Was Device Available for Evaluation?: No
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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