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

Catalog Number	75HA70
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
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 the incident occurred when changing the tracheostomy tube.The patient's cannula was inserted after performing the cuff test on the device.After a short time iv ventilation could no longer be ensured.This was accompanied by a drop in spo2.The cuff pressure was no longer measurable and the nursing service had to call the emergency doctor.The patient was admitted to the hospital as an emergency.In the hospital, the cannula was changed again and it was noticed that it was the wrong cannula.There was patient involvement and unknown patient harm.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.It was reported that complaint identified for this lot number and no other complaints for mislabeled products on part numbers 75ha70 or 67ha70.Based on review of the pictures, the returned items, and the dhr, a conclusion could not be made that the wrong product was a manufacturing fault.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20152720
• Report Number: 1824231-2024-00081
• Device Sequence Number: 4248639
• Product Code: JOH
• UDI-Device Identifier: 15021312013849
• UDI-Public: (01)15021312013849(17)271208(10)4354823
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: Other
• Device Catalogue Number: 75HA70
• Device Lot Number: 4354823
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown