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

Catalog Number	100/133/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: no sample was returned for evaluation.No photos were provided by the customer.The customer reported failure mode could not be confirmed.A batch review of the lot number was completed and no non-conformances were found.If the product is returned, this complaint will be reopened for further investigation.
Event or Problem Description
It was reported that an anesthesiologist intubated a patient with a size 7.5 (lot 4419510) smiths medical portex polar preformed nasal tracheal tube for facio-maxillary surgery and as it was attempted to inflate the cuff, it was noticed that there was a leak and therefore it was unable to inflate the cuff.The tube was removed from the patient and then intubated using a new size 7.5 tube (lot 4419510) and the same issue was experienced.Then the patient was intubated with a size 7.0 tube (lot 4439675) and this time same issue was experienced.Care was taken on intubation and no forceps or otherwise were used that could have damaged any of the cuffs.Following this incident, all three defective tubes were tested underneath water and found that in all three the leak appears to be on the seal of the cuff itself.After discussing the incident it was confirmed by another anesthesiologist that similar issues were experienced recently after attempting to intubate with multiple of these tubes.Other tubes were personally tested from the same lot numbers and it appears that the defect is inconsistent as some are defective and some are functional.The event occurred on (b)(6) 2024 there was patient involvement and no patient harm/adverse event reported.

• Brand Name: PORTEX ENDOTRACHEAL TUBES POLAR
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19536832
• Report Number: 3012307300-2024-04969
• Device Sequence Number: 8252109
• Product Code: BTR
• UDI-Device Identifier: 15019315020353
• UDI-Public: 15019315020353
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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: 100/133/070
• Device Lot Number: 4439675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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