MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CUSTOM 4.0 TTS FLEXTEND NS; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT24KN40NGF205N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
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 showed asymmetry during inflation post-sterilization.There were no patient harm or adverse events reported as a result of the event.
Additional Manufacturer Narrative
D9: date returned to mfg.: 2/11/2025 h3 and h6.Codes: updated.Device evaluation: two custom tracheostomy products were received.No damage was observed during visual inspection.The customer reported issue ¿the cuff showed asymmetry during inflation post-sterilization¿ was not confirmed.The investigation determined that the cuff symmetry for both devices met the manufacturing specification.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: CUSTOM 4.0 TTS FLEXTEND NS
• 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: 21357843
• Report Number: 1824231-2025-00012
• Device Sequence Number: 8451602
• Product Code: JOH
• UDI-Device Identifier: 15019517200812
• UDI-Public: (01)15019517200812(17)250108(10)GB031844
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: FT24KN40NGF205N
• Device Lot Number: GB031844
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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