MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	175030
Medical Device Problem Codes	Gas/Air Leak (2946); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "(b)(6) 2025, the doctor found cuff leakage when doing testing before using on patient.After inflating the syringe, the balloon cannot maintain pressure.Change new tube.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2025, the doctor found cuff leakage when doing testing before using on patient.After inflating the syringe, the balloon cannot maintain pressure.Change new tube.".
Additional Manufacturer Narrative
(b)(4).The reported issue of cuff leakage could not be confirmed upon investigation of the returned sample.The customer returned an actual sample for evaluation.Based on visual inspection and functional test of the actual returned sample, no defect was observed on sample and no problem found on sample returned.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.

• Brand Name: LMA SUPREME SIZE 3
• 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: 24018500
• Report Number: 3009307931-2026-00006
• Device Sequence Number: 8970203
• Product Code: CAE
• UDI-Device Identifier: 15060112319928
• UDI-Public: (01)15060112319928(11)250523(17)280522(10)11F25E0202(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 175030
• Device Lot Number: 11F25E0202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/18/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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
• Patient Sex: Unknown