MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Catalog Number 175040

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) based on the complaint description and review of dhr for the affected lot, there is no abnormalities was identified.There was also no nc was raised during the production of the lot.The actual sample was not received to evaluate / review the actual sample.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".

Event Description

It was reported that on (b)(6) 2023, the doctor found cuff leakage when using on patient.Additional information: the patient was reintubated with a different device successfully.There was no reported patient harm or impact on health.

• Brand Name: LMA SUPREME SIZE 4
• Type of Device: 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18910649
• MDR Text Key: 337729791
• Report Number: 8040412-2024-00078
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 05060112310829
• UDI-Public: 05060112310829
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 175040
• Device Lot Number: 11F22E0393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED
• Patient Outcome(s): Required Intervention