MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA HYPTERFLEX; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	67HA80
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 phone number: (b)(6).A product sample was received and is awaiting evaluation, 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 stated that the cuff leakage was found after ten days while in use with a patient.The event occurred while in use with patient.The date of event was on (b)(6) 2025.The operator of device was a health professional.The event occurred in hospital.There was no report of adverse event.
Additional Manufacturer Narrative
One used unit was received for evaluation.No visual defects were observed upon initial inspection.Functional testing was performed and the reported issue was repliceated.A device history review was performed and no nonconformances were identified.The reported defect was able to be replicated, and no misuse was identified.The defect is confirmed and can be attributed to the manufacturing process.The true lot number cannot be confirmed due to the packaging being discarded.Customer reported the assumed lot number:.

• Brand Name: BIVONA HYPTERFLEX
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 21276740
• Report Number: 1824231-2025-00009
• Device Sequence Number: 11673058
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: (01)15021312013818(17)271122(10)4346853
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 67HA80
• Device Lot Number: 4346853
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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