MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 2.5; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	175025
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "air leaked from the device during the test before use.Therefore, a new unit was used instead".No patient involvement.
Event or Problem Description
It was reported that "air leaked from the device during the test before use.Therefore, a new unit was used instead".No patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "air leaked from the device during the test before use.Therefore, a new unit was used instead".No patient involvement.
Additional Manufacturer Narrative
(b)(4).One actual sample received for investigation in opened packaging.The lot number printed on the pouch packaging was verified as 11f24h0093 for finished good product code 175025.Upon visual inspection, no abnormalities were observed on the returned sample.Upon functional inspection performed, the tear location was further investigate using keyence digital microscope.It was observed that the inner edge of cuff was not secured to the overmould backplate at the tip area.This condition does not comply with the manufacturing assembly of supreme pediatric step 6 & 7 glue inner edge of cuff to overmould backplate which specified applying delo glue at overmould backplate tip portion and secure the cuff.Functional testing was performed by inflating the lma cuff.The cuff was initially able to inflate; however, it gradually deflated after inflation.A leak test was performed on the cuff by immersing the cuff in water and reinflating the cuff.Air bubbles were observed coming out from the water indicating the presence of leak and leakage area has been identified.Instruction for use (ifu) has been reviewed at pre-use performance tests section stated " do not use the device should it fail any one of the following inspections or tests deflate the cuff fully.Once deflated, check the cuff for spontaneous inflation.Do not use the device if the cuff spontaneously inflates".Based on the investigation conducted on the returned actual complaint sample, it was found that the returned sample was confirmed and verified as a manufacturing process issue.A non-conformance has been initiated to further investigate the issue.A device history record (dhr) was reviewed; no issue related to complaint was noted.Other remarks: n/a.Corrected data: n/a.

• Brand Name: LMA SUPREME SIZE 2.5
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22894296
• Report Number: 3009307931-2025-00030
• Device Sequence Number: 5802627
• Product Code: CAE
• UDI-Device Identifier: 15060112319911
• UDI-Public: (01)15060112319911(11)240817(17)270817(10)11F24H0093(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 08/12/2025

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: 175025
• Device Lot Number: 11F24H0093
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 11/11/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/09/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2024
• 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: N/A.; N/A.; N/A.
• Patient Sex: Unknown