MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670190
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that water could not be injected into the cuff after being used for one week.There was no medical intervention required.There was unknown patient harm or adverse event reported as a result of the event.
Additional Manufacturer Narrative
One device was received for evaluation for the complaint that water could not be injected into the cuff after being used for one week.Although the actual lot number is unknown, a review of the customer's assumed lot dhr was executed for the part#: 670190 and lot#: 4462511.There are no ncmrs associated with the lot and no complaint trending identified for the part.From visual inspection and leak testing, the defect is observed.Customer report shows product in use for 1 week prior to failure.Based on the evidence submitted and reviewed, the defect was not caused by the manufacturing process.The exact cause of the defect is unknown but can be surmised to 1 of the following options due to improper handling of the device, excessive motion as described in 10018908-001 section 4.7.And the returned device was incompatible with the patient's anatomy and was the incorrect size and shape chosen by the healthcare provider.Due to this information, the defect is observed but cannot be attributed to the manufacturing process.

• Brand Name: BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE
• 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: 21777713
• Report Number: 3012307300-2025-03802
• Device Sequence Number: 18104011
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: (01)15021312006094(17)290612(10)4462511
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 02/02/2026

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: 670190
• Device Lot Number: 4462511
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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