MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Catalog Number	175040
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "cuff leak during use on patient".Additional information has been requested from the account.
Additional Manufacturer Narrative
(b)(4).The complaint was concluded as not confirmed as the root cause is "undetermined".The issued was unable to be identified.No complaint samples were returned for further evaluation / investigation.
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of cuff leak was confirmed based upon the investigation of the sample received.Functional testing identified a leakage on the balloon area of the returned sample.A device history record review was performed, and no relevant findings were identified.The root cause of this issue was 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: "cuff leak during use on patient".Additional information has been requested from the account.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19297346
• Report Number: 3009307931-2024-00013
• Device Sequence Number: 20297453
• Product Code: CAE
• UDI-Device Identifier: 05060112310829
• UDI-Public: 05060112310829
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (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): 04/17/2024

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: 02/06/2026
• Device Catalogue Number: 175040
• Device Lot Number: 11F23B0087
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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