MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. NEONATAL TRACHEOSTOMY TUBE 4.0 TTS FLEXTEND STRAIGHT FLANGE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67NFPS40
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two trach¿s were reported with the issue, the cuffs were not inflating properly, the cuff got stuck on one side and does not inflate full like a balloon.Rushed two more trachs (same lot) and the client had the same issue.There was no patient involvement and no patient harm/adverse event reported.
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 information becomes available.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: four used samples were received for evaluation.The samples were visually and functionally tested and the cuff of each set was observed to inflate as normal.The customer reported complaint was not able to be replicated or confirmed.The product's history records were reviewed and there were no non-conformances that would have resulted in the reported complaint.

• Brand Name: NEONATAL TRACHEOSTOMY TUBE 4.0 TTS FLEXTEND STRAIGHT FLANGE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21241927
• Report Number: 3012307300-2025-01154
• Device Sequence Number: 8495794
• Product Code: JOH
• UDI-Device Identifier: 10351688518804
• UDI-Public: (01)10351688518804(17)290926(10)6035236
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 67NFPS40
• Device Lot Number: 6035236
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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 Sex: Unknown