MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3

Catalog Number 175030

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint reported as: "found lma supreme gas tube leaking." additional information was requested, but not received at the time of this report.

Manufacturer Narrative

(b)(4).The sample was returned and sent to the manufacturing site in kulim, malaysia for investigation.The manufacturer reports that the sample was subjected to a cuff leak test and no leaks were detected.The dhr was reviewed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.

Event Description

Complaint reported as: "found lma supreme gas tube leaking." additional information was requested, but not received at the time of this report.

• Brand Name: LMA SUPREME SIZE 3
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9378043
• MDR Text Key: 182597483
• Report Number: 9681900-2019-00051
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

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 Operator: No Information
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 175030
• Device Lot Number: PMAKVM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/30/2019
• Supplement Dates FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.