MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TRACHEAL TUBE MAXILLO FACIAL; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/133/065
Medical Device Problem Codes	Inflation Problem (1310); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other, other text: 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 by healthcare personnel that they had a faulty valve on a tracheal tube.The cuff wouldn't hold the inflation pressure once inserted.No injury or adverse effects reported.The tube was exchanged using a catheter.The fault was discovered by the anesthetist after the product was exchanged.
Additional Manufacturer Narrative
The physical sample was not returned for investigation, the customer provided a video of the event for evaluation.The video describes an underwater test, the pilot balloon was submerged water, squeezed and bubbles are observed near the connector joint to the pilot balloon.The customer reported a faulty valve, however in the video a leak was identified near the bonding of the pilot balloon and the valve.Based on the analysis conducted and the physical sample not returned for analysis of the leak, the root cause cannot be associated with the manufacturing process.The product's history record was reviewed and there were no non-conformances that would have resulted in the reported complaint.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).

• Brand Name: PORTEX TRACHEAL TUBE MAXILLO FACIAL
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17430798
• Report Number: 3012307300-2023-07628
• Device Sequence Number: 15241997
• Product Code: BTR
• UDI-Device Identifier: 15019315020346
• UDI-Public: 15019315020346
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 100/133/065
• Device Lot Number: 4217920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown