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

Catalog Number	XT25BS55NGF207N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
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 the cuff did not seem to inflate and only the pilot balloon was inflating.There was no patient harm or adverse events reported.The event occurred after initial sterilization.They attempted to check the cuff with 5, 10 & 15 cc of water multiple times but still cuff did not inflate.
Additional Manufacturer Narrative
One used sample was received for evaluation for the complaint that the cuff did not seem to inflate and only the pilot balloon was inflating.During lot history review the lot gc001620 for (b)(4) devices was manufactured 28 february 2025.There were no ncmrs initiated for this lot.Using a syringe, 5 ml of water was inserted in the inflation valve.The fluid remained in the pilot balloon.Following instructions in the ifu, 10018908-001, under 6.0 setup and use, the cuff inflated.

• Brand Name: BIVONA CUSTOM FLEXTEND
• 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: 21746955
• Report Number: 3012307300-2025-03600
• Device Sequence Number: 9437260
• Product Code: JOH
• UDI-Device Identifier: 10887709149127
• UDI-Public: (01)10887709149127(17)300228(10)GC001620
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: XT25BS55NGF207N
• Device Lot Number: GC001620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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