MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670170
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tube cuff could not be deflated, and the water could not be removed.The nurse cut the inflation line, inserted a needle into it, and gradually aspirated the cuff's contents.The event took place at the patient's home and was conducted by a health professional.There was unknown patient harm reported as a result of the event.
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.
Additional Manufacturer Narrative
H2) device evaluation: h3, h6: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.
Additional Manufacturer Narrative
One used device was received for evaluation.Functional and visual tests were done and the reported issue was duplicated.The probable cause of the particulates observed is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22079079
• Report Number: 3012307300-2025-06097
• Device Sequence Number: 15586123
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: (01)15021312006056(17)230811(10)441114
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2025

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 Catalogue Number: 670170
• Device Lot Number: 4411145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 09/18/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/11/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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