MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE EVO CUFF PILOT SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	1D2040
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the lma came apart.The cuff of the lma evo separated from the device and was in the patient's airway (they had to pull it out).No damage done to the patient.".
Additional Manufacturer Narrative
(b)(4).The reported issue 'cuff separated from tube' was confirmed upon investigation of the returned sample.The customer returned an actual sample for investigation.Visual inspection shows that the cuff was separated from the tube at the backplate and tube junction, with a portion of the backplate still attached to the tube.The tear on the backplate appears irregular, indicating that the cuff was forcibly detached from the tube.Further examination of the backplate shows traces of adhesive still present inside the backplate-tube junction.A device history record review was performed, and no relevant findings were identified.The tear on the backplate appears irregular, indicating that the cuff was forcibly detached from the tube.However, the root cause of the defect remains undetermined at this stage.Teleflex will continue to monitor and trend for events of this nature.
Event or Problem Description
It was reported that "the lma came apart.The cuff of the lma evo separated from the device and was in the patient's airway (they had to pull it out).No damage done to the patient.".

• Brand Name: LMA UNIQUE EVO CUFF PILOT SIZE 4
• 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: 24321281
• Report Number: 3009307931-2026-00011
• Device Sequence Number: 9674606
• Product Code: CAE
• UDI-Device Identifier: 15060112318884
• UDI-Public: (01)15060112318884(11)240725(17)270725(10)11F24G0200(21)
• Combination Product (Y/N): N
• 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): 01/21/2026

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: 1D2040
• Device Lot Number: 11F24G0200
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown