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

Catalog Number	100/136/080
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a leak test of the ett was carried out before start of anaesthetic.During intubation with a size 8 rae tube, the cuff was inflated, but the balloon began to deflate spontaneously.Faulty tube was removed and replaced it with a new size 8 rae tube, same lot number.Post intubation, a test was carried out on the defective rae tube by inflating the cuff while the balloon was submerged in water, revealed bubbles escaping from tip of the tube but not around the balloon.There was patient involvement and no adverse harm reported.
Additional Manufacturer Narrative
One used sample was received for evaluation for the complaint that a leak test of the ett was carried out before start of anesthetic.During intubation with a size 8 rae tube, the cuff was inflated, but the balloon began to deflate spontaneously.As received, there was no physical damage or other anomalies observed.The device history file was reviewed.There were no discrepancies noted relevant to the indicated failure mode.In attempts to replicate clinical use the tracheal tube was inflated using an icu medical provided syringe.It was observed that the cuff inflated however it deflated.The cuff was inflated again and put in a water bath.A leak was observed to be coming at the end of the main tube.The customer complaint was confirmed of balloon deflates spontaneously, probable cause failure in the end form process during assembly.

• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22935122
• Report Number: 3012307300-2025-10176
• Device Sequence Number: 9768505
• Product Code: BTR
• UDI-Device Identifier: 15019315021459
• UDI-Public: (01)15019315021459(17)291101(10)6060155
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (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): 03/24/2026

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: 100/136/080
• Device Lot Number: 6060155
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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