MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX MAXILLOFACIAL ENDOTRACHEAL TUBE W/ CUFF; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/133/060
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Event or Problem Description
It was reported that once in the tube was in the patient and the cuff was inflated, there was a massive air leak.The anesthetist could not adequately ventilate the patient.Through troubleshooting, it was determined that the leak was originating from the tube, but the tube cuff was not compromised.The leak was occurring at the valve where the air was introduced into the tube to inflate the cuff.This valve issue resulted in air leakage from the balloon and cuff of the tube.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Device evaluation: one photo was received for evaluation.Per photo received, the location of the failure was indicated, however no evidence of leak was observed.Six samples were received in unused condition within original package.Samples were visually and functionally tested and no discrepancies or leaks were detected.The leaking failure mode was not confirmed.A root cause could not be confirmed since the failure mode was not confirmed.No action taken is required since the complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX MAXILLOFACIAL ENDOTRACHEAL TUBE W/ CUFF
• Common Device Name: TUBE, TRACHEAL (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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20798542
• Report Number: 9617604-2024-00896
• Device Sequence Number: 6764091
• Product Code: BTR
• UDI-Device Identifier: 15019315020339
• UDI-Public: (01)15019315020339(17)290606(10)6010647
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K931735
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 100/133/060
• Device Lot Number: 6010647
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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