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

Catalog Number	175030
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the doctor found cuff leakage when using on patient.Change new tube".No patient harm or injury.The patient did not desaturate during the event.The patient status is reported as "fine".
Event or Problem Description
It was reported that "the doctor found cuff leakage when using on patient.Change new tube".No patient harm or injury.The patient did not desaturate during the event.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported issue of cuff leak was confirmed upon investigation of the returned sample.The customer returned an actual sample for investigation.A device history record review was performed, and no relevant findings were identified.Based on the investigation conducted, it was found that tears and holes were present on the top and bottom of the cuff at the proximal end of the lma, causing leakage as reported in the complaint.One of the tears appeared straight, and a hole was observed when the cuff was inflated.Another tear appeared irregular and jagged, indicating it was not a clean cut.However, the root cause of the defect remains undetermined at this stage.Therefore, corrective action is not required since the root cause has not been identified.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• 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 27560
• MDR Report Key: 23595647
• Report Number: 3009307931-2025-00044
• Device Sequence Number: 13083947
• Product Code: CAE
• UDI-Device Identifier: 05060112310812
• UDI-Public: (01)05060112310812(11)240825(17)270825(10)11F24H0159(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 11F24H0159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2024
• 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