MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY FOME CUFF TUBES WITH TALK ATTCHMENT; " TUBE TRACHEOSTOMY AND TUBE CUFF"

Catalog Number	855170
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.H3: device not returned to manufacturer.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 the white ring of the tracheostomy came apart the first time they tried to pull out the tube.There was unknown patient involvement and unknown patient harm/adverse reported.
Additional Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.Based on the complaint details, the investigation determined it was likely that the disconnect wedge was not used or that there was an attempt to remove the device swivel, which is not designed to be removed; either action could result in the issue reported in the complaint.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: BIVONA TRACHEOSTOMY FOME CUFF TUBES WITH TALK ATTCHMENT
• Common Device Name: " TUBE TRACHEOSTOMY AND TUBE CUFF"
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20483279
• Report Number: 1824231-2024-00086
• Device Sequence Number: 14479519
• Product Code: JOH
• UDI-Device Identifier: 15021312006902
• UDI-Public: (01)15021312006902(17)260713(10)4128089
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 07/13/2026
• Device Catalogue Number: 855170
• Device Lot Number: 4128089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/25/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown