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

Catalog Number	175030
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
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.Change new tube.".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of cuff leakage could not be confirmed upon investigation of the returned sample.The customer returned the actual sample for investigation.Based on the investigation of the returned sample, the product was able to be inflated and deflated without any issues and no leakage observed.A device history record review was performed, and no relevant findings were identified.Therefore, the complaint description stating that the cuff leakage could not be confirmed.No problem found on the returned actual sample; thus, the complaint could not be confirmed.
Event or Problem Description
It was reported that: "(b)(6) 2025, the doctor found cuff leakage when doing testing before using on patient.Change new tube.".

• 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: 22794490
• Report Number: 3009307931-2025-00027
• Device Sequence Number: 18270626
• Product Code: CAE
• UDI-Device Identifier: 15060112318082
• UDI-Public: (01)15060112318082(11)231124(17)261123(10)11F23L0085(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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 11F23L0085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown