MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE EVO CUFF PILOT SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	1D2050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "lma was used in the intubation of a patient, but it wouldn't stay inflated.A new one was obtained and worked.No patient harm reported.".
Additional Manufacturer Narrative
(b)(4).One actual sample received for investigation.An initial visual inspection of the returned sample showed no obvious abnormalities.Post-functional testing, a visual inspection of the cuff pilot valve was conducted using the keyence digital microscope, during which a hole was observed at the seal area of the cuff pilot valve.The hole was confirmed to be the source of leak where bubbles were observed emerging from during water leak test.Functional testing was conducted in accordance.The cuff was inflated to the upper limit (green zone) of the cuff pilot.The inflated cuff was then left for 60 minutes and monitored using a timer.After 5 minutes, the black indicator line shifted from the green zone to the yellow zone, indicating that a leak was present.To confirm the leak location, the sample was inflated and immersed in a water bath.Bubbles were observed emerging from the bottom of the cuff pilot valve, near the inflation line.This confirmed that the complaint of the sample not maintaining inflation was due to a leak at the cuff pilot valve.A device history record (dhr) review was conducted for the lot number with no relevant findings.Based on the investigation conducted, a leak was identified at the cuff pilot valve.The cuff was inflated and left for 60 minutes.After 5 minutes, the black indicator line shifted from the green zone to the yellow zone, indicating the presence of a leak.Subsequent visual inspection of the cuff pilot valve revealed a hole at the seal area, which was determined to be the source of the leak.This confirmed that the complaint regarding the sample's inability to maintain inflation was due to a leak at the cuff pilot valve.Further investigation of this confirmed issue will be documented in a newly initiated nonconformance report.
Event or Problem Description
It was reported that: "lma was used in the intubation of a patient, but it wouldn't stay inflated.A new one was obtained and worked.No patient harm reported.".

• Brand Name: LMA UNIQUE EVO CUFF PILOT SIZE 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24727618
• Report Number: 3009307931-2026-00014
• Device Sequence Number: 9286440
• Product Code: CAE
• UDI-Device Identifier: 15060112318891
• UDI-Public: (01)15060112318891(11)250619(17)280618(10)11F25F0147(21)
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 1D2050
• Device Lot Number: 11F25F0147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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