MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 3; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	105200-000030
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "this lma was inserted into the patient and was quickly removed when the caa noticed that there was a piece of fragment inside the tube of the lma.It was removed immediately and no harm or consequence was reported.".
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint was confirmed upon investigation of the returned sample.The customer returned an actual sample for investigation and loose foreign material was observed at the distal end of the airway tube.Dimensional inspection has been performed, and the measurement of the loose foreign matter exceeded the allowable limits in the applicable inspection specification for the lma unique (silicone cuff) and its associated cuff pilot.The foreign material was identified as a flashing debris from the molding process.A device history record review was performed, and no relevant findings were identified.Based on the investigation, the root cause of this reported issues has been determined to be manufacturing related.Further investigation has been initiated under teleflex quality systems to evaluate this issue.
Event or Problem Description
It was reported that: "this lma was inserted into the patient and was quickly removed when the caa noticed that there was a piece of fragment inside the tube of the lma.It was removed immediately and no harm or consequence was reported.".

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22505663
• Report Number: 3009307931-2025-00024
• Device Sequence Number: 21182932
• Product Code: CAE
• UDI-Device Identifier: 05060112313578
• UDI-Public: (01)05060112313578(11)240927(17)270927(10)11F24J0080(21)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 105200-000030
• Device Lot Number: 11F24J0080
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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