MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE PILOT BALLOON SIZE 3; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	105300-000030
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2026, the doctor found cuff leakage when doing testing before using on patient.Change new tube.".
Additional Manufacturer Narrative
Qn# (b)(4) based on the investigation conducted, a leak was observed in the returned sample.A deep tear penetrating through the cuff was ident ified, extending from the outer surface to the inner surface of the cuff spigot.The observed deep, irregular through-wall tear suggests the possibility of contact with a sharp edge or tool, or the application of excessive force during pre-use handling, potentially occurring during movement of the connected syringe to stretch the inflation line prior to cuff deflation, as described in ifu.Functional testing of the returned sample demonstrated a pressure drop upon inflation, and the pressure could not be maintained, indicating the presence of a leak.Therefore, the complaint of cuff leakage was confirmed.However, the exact root cause of the defect could not be definitively determined at this stage.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that"(b)(6) 2026, the doctor found cuff leakage when doing testing before using on patient.Change new tube.".

• Brand Name: LMA UNIQUE SILICONE PILOT BALLOON 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24765275
• Report Number: 3009307931-2026-00015
• Device Sequence Number: 9349042
• Product Code: CAE
• UDI-Device Identifier: 15060112319355
• UDI-Public: (01)15060112319355(11)250614(17)280613(10)11F25F0048(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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 105300-000030
• Device Lot Number: 11F25F0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2025
• 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