MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	175040
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2025, the doctor found cuff leakage when using on patient.Change new one.The second one also found cuff leakage during use.Change the third one.There was no reported patient harm or consequence." associated complaints 3009307931-2025-00038.
Event or Problem Description
It was reported that: "(b)(6) 2025, the doctor found cuff leakage when using on patient.Change new one.The second one also found cuff leakage during use.Change the third one.There was no reported patient harm or consequence." associated complaints 3009307931-2025-00039 and 3009307931-2025-00038.
Additional Manufacturer Narrative
(b)(4).The customer complaint was confirmed through the investigation of the returned sample.The customer returned an actual sample was received for investigation.Functional and visual testing confirmed the presence of leakage due to a tear on the cuff of the laryngeal mask.According to ifu, a pre-use performance test must be conducted prior to use.During this test, the user is required to inspect the surface of the laryngeal mask to ensure it is free from cuts, tears, scratches, and kinks.Furthermore, the cuff must be successfully inflated and deflated before use.A device history record review was performed and there were no relevant findings.A review of manufacturing process revealed that the cuff undergoes a 100% inspection during manufacturing to ensure product integrity.Therefore, the root cause of the tear could not be determined, as the defect was not present during manufacturing inspection and may have occurred post-manufacture or during use.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: LMA SUPREME SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY (M) SDN. BHD; lot 19 , jalan hi-tech 3; zon industri fasa 1, kulim hi-tech park; kulim kedah 09090 ; MY 09090
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23265532
• Report Number: 3009307931-2025-00039
• Device Sequence Number: 18687341
• Product Code: CAE
• UDI-Device Identifier: 05060112310829
• UDI-Public: (01)05060112310829(11)240821(17)270821(10)11F24H0151(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: 175040
• Device Lot Number: 11F24H0151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown