MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 2; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	105200-000020
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "we had an lma in a patient today who was having a procedure with a flexible bronchoscope.When they went down the lma they found a small piece of plastic sitting on the inside on the tube.The plastic was removed with forceps and procedure went ahead, with no delay or adverse issues.".
Event or Problem Description
It was reported that: "we had an lma in a patient today who was having a procedure with a flexible bronchoscope.When they went down the lma, they found a small piece of plastic sitting on the inside on the tube.The plastic was removed with forceps and procedure went ahead, with no delay or adverse issues.".
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of 'foreign material inside the lma tube' was confirmed based upon the review of customer supplied pictures.The complaint device was not returned to our manufacturing site for investigation.A device history record review was performed, and no relevant findings were identified.Based on the investigation, the root cause of this issue was identified as being related to the manufacturing process.Further investigation has been initiated under the teleflex quality system to evaluate this issue.

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 2
• 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: 21812035
• Report Number: 3009307931-2025-00007
• Device Sequence Number: 21076185
• Product Code: CAE
• UDI-Device Identifier: 15060112319256
• UDI-Public: (01)15060112319256(11)240309(17)270309(10)11F24C0045(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/21/2025

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: 105200-000020
• Device Lot Number: 11F24C0045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2024
• 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