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

Catalog Number	FT23LN55NGF132N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 eye loops on a few trachs tore.Event occurred while in use with patient.This was not reported to the fda.Operator of the device was a lay user/patient.Event occurred at home.The issue was not resolved.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6: codes were updated.No device was received for investigation.Therefore, the reported complaint is unable to be confirmed.If the device is received, the investigation will be re-opened for further evaluations.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA CUSTOM 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: 21596168
• Report Number: 3012307300-2025-02809
• Device Sequence Number: 12844818
• Product Code: JOH
• UDI-Device Identifier: 15019517369922
• UDI-Public: (01)15019517369922(17)290611(10)GB021976
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: FT23LN55NGF132N
• Device Lot Number: GB021976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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 Age: 6 YR
• Patient Sex: Unknown
• Patient Weight: 18 KG
• Patient Race: White