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	12/23/2025
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 tube.The patient was reported as fine.There was no reported harm or consequence.".
Additional Manufacturer Narrative
(b)(4).The reported complaint of cuff leakage could not be confirmed based upon the investigation of the sample received.The customer returned an actual sample for investigation.Based on visual inspection of the actual returned sample, no defect was observed on sample.Functional testing was performed by inflating the cuff and no pressure decrease was observed, indicating that no leak or slow leak was present; the pressure remained stable.A device history record review was performed, and no relevant findings were identified.Based on the investigation of the returned complaint device, no issues were found.
Event or Problem Description
It was reported that: "(b)(6) 2025, the doctor found cuff leakage when using on patient.Change new tube.The patient was reported as fine.There was no reported harm or consequence.".

• 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: 24092906
• Report Number: 3009307931-2026-00009
• Device Sequence Number: 10296015
• Product Code: CAE
• UDI-Device Identifier: 15060112319935
• UDI-Public: (01)15060112319935(11)250706(17)280705(10)11F25G0014(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): 12/26/2025

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: 11F25G0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2025
• 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