MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/815/070
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Additional contact: (b)(6).H3: other; device not returned to manufacturer.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Event or Problem Description
It was reported that there was the presence of water (condensation) in the cuff, as well as the balloon tubing, during the last cannula change.Trach installed on (b)(6) 2023, and changed on (b)(6) 2024 (documented on (b)(4)).The trach installed on (b)(6) was changed on (b)(6) and the hospital noted the same thing: moisture in the main balloon (0.5 cc removed).There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
One used sample was received for evaluation.Visual and functional testing was unable to verify or duplicate the reported problem.A device history record review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19315667
• Report Number: 9617604-2024-00446
• Device Sequence Number: 16913347
• Product Code: BTO
• UDI-Device Identifier: 10351688009265
• UDI-Public: (01)10351688009265(17)260108(10)4032511
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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 Expiration Date: 01/08/2026
• Device Catalogue Number: 101/815/070
• Device Lot Number: 4032511
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2021
• 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