MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 1; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	105200-000050
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "cuff loses air.The patient's oxygen saturated dropped below 95%.Another device was used to finish the procedure.They were reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).The reported issue of cuff leak was confirmed upon investigation of the returned sample.An actual sample and two representative samples were returned for analysis.Functional testing performed on the actual sample confirmed leakage through the sealing on the cuff pilot.In contrast, the representative samples were subjected to a bubble leak test, and no issues were observed.A device history record review was performed, and no relevant findings were identified.Further investigation has been initiated under teleflex quality systems to evaluate this issue.
Event or Problem Description
It was reported that "cuff loses air.The patient's oxygen saturated dropped below 95%.Another device was used to finish the procedure.They were reported as fine psot thte procedure.".

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 1
• 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: 23366070
• Report Number: 8040412-2025-00249
• Device Sequence Number: 10089571
• Product Code: CAE
• UDI-Device Identifier: 15060112318990
• UDI-Public: (01)15060112318990(11)230321(17)260320(10)11F23C0255(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/30/2025

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 Expiration Date: 03/20/2026
• Device Catalogue Number: 105200-000050
• Device Lot Number: 11F23C0255
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown