MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Catalog Number 175040

Device Problem Gas/Air Leak (2946)

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

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: (b)(6) 2023, after placement, there was air leakage, some gas entered the stomach, and the condition did not improve after manual breathing for 2 minutes.After placement again, there was still air leakage.The tracheal intubation was immediately replaced, and the surgery was successfully completed.

Event Description

It was reported that: (b)(6) 2023, after placement, there was air leakage, some gas entered the stomach, and the condition did not improve after manual breathing for 2 minutes.After placement again, there was still air leakage.The tracheal intubation was immediately replaced, and the surgery was successfully completed.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18493431
• MDR Text Key: 332670283
• Report Number: 3009307931-2024-00003
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

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 Catalogue Number: 175040
• Device Lot Number: 11F22M0279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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; NOT REPORTED