MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 4; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	105200-000040
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it was brought to my attention that we have had 4 devices that would not deflate prior to use.The issue was identified prior to use." associated complaints 3009307931-2025-00005 and 3009307931-2025-00004.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "it was brought to my attention that we have had 4 devices that would not deflate prior to use.The issue was identified prior to use." associated complaints 3009307931-2025-00006, 3009307931-2025-00005 and 3009307931-2025-00004.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of the cuff non-deflation prior to use could not be confirmed based on the sample received.The customer returned the sample with the packaging couch and syringe.Visual inspection of the returned sample revealed no defects or anomalies observed.The cuff passed the inflation and deflation test during functional inspection.A dhr review was performed, and no evidence was found to suggest a manufacturing related cause.Based on the investigation of the returned complaint device, no issues were found.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 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: 21811959
• Report Number: 3009307931-2025-00006
• Device Sequence Number: 20670260
• Product Code: CAE
• UDI-Device Identifier: 15060112319287
• UDI-Public: (01)15060112319287(11)240720(17)270720(10)11F24G0108(21)
• Combination Product (Y/N): N
• 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): 03/20/2025

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: 105200-000040
• Device Lot Number: 11F24G0108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2024
• 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