MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Catalog Number	175040
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: (b)(6).2023, the surgery requires the insertion of a laryngeal mask, which is difficult to insert and causes air leakage during the process.Patient reported as good post the procedure.
Additional Manufacturer Narrative
Qn#(b)(4) the sample was not returned to the manufacturer.The manufacturer reported: "no actual sample was received for further investigation.Based on the complaint description and review of dhr for the affected lot, there is no abnormalities was identified.There was also no nc raised during the production of the lot.As there was no complaint sample was returned to confirmed on the actual root cause, then the root cause for this complaint is concluded as 'undetermined/unknown'.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: (b)(6) 2023, the surgery requires the insertion of a laryngeal mask, which is difficult to insert and causes air leakage during the process.Patient reported as good post the procedure.

• Brand Name: LMA SUPREME SIZE 4
• Common Device Name: LMA SUPREME
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18518023
• Report Number: 3009307931-2024-00001
• Device Sequence Number: 15342862
• Product Code: CAE
• UDI-Device Identifier: 05060112310829
• UDI-Public: 05060112310829
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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
• Device Expiration Date: 07/19/2025
• Device Catalogue Number: 175040
• Device Lot Number: 11F22G0327
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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