MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3

Catalog Number	175030
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "there was leaking from the balloon with lma supreme when intubatating the patient.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, "there was leaking from the balloon with lma supreme when intubatating the patient".
Additional Manufacturer Narrative
Qn# (b)(4).The sample was returned for evaluation.The manufacturing site reports that a leak test was performed om the returned sample and a leak was confirmed as there was a small tear found on the cuff.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the complaint was confirmed.The root cause of the cuff leak was identified as manufacturing related.A non-conformance was opened to address this issue.

• Brand Name: LMA SUPREME SIZE 3
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19278054
• Report Number: 3009307931-2024-00015
• Device Sequence Number: 12352077
• Product Code: CAE
• UDI-Device Identifier: 05060112310812
• UDI-Public: 05060112310812
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/15/2024

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: 03/01/2026
• Device Catalogue Number: 175030
• Device Lot Number: 11F23C0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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