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

Catalog Number	ZT23BN60NSB029N
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
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 they only noticed it when the cuff was inflated that the patient immediately began coughing.They changed the trach and checked the cuff, discovering it had a hole in it.The patient needed immediate suction of the airway as water was leaking into the trachea.To resolve the issue, the trach was changed.There was patient involvement and there was patient harm reported.
Additional Manufacturer Narrative
H3: one used unit was received for evaluation.During visual inspection, no defects were observed.Functional testing confirmed the reported issue and a leak was observed in the device cuff band.Custom tracheostomy devices are leak tested twice during final functional testing; therefore, the leak cannot be attributed to the manufacturing process.A lot history review was performed and no nonconformances were identified.

• Brand Name: BIVONA FLEXTEND 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20171406
• Report Number: 1824231-2024-00082
• Device Sequence Number: 15232145
• Product Code: JOH
• UDI-Device Identifier: 15019517333473
• UDI-Public: (01)15019517333473(17)290312(10)GB018252
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• 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: Health Professional
• Device Catalogue Number: ZT23BN60NSB029N
• Device Lot Number: GB018252
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Unknown
• Patient Weight: 44 KG
• Patient Race: White