MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3

Model Number IPN922810

Device Problem Obstruction of Flow (2423)

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

Event Date 01/11/2023

Event Type  malfunction  

Event Description

Reported event: after placement the user was unable to insert a stomach tube through the lma.Therefore, the lma was replaced with a new one.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

Qn#(b)(4).The device was returned by the customer and sent to the manufacturing site for evaluation.The manufacturing site reports that a visual exam was performed and it was observed that there was a kink at the drain tube area of the device.A kink test was performed by inserting a gastric tube into the complaint sample.It was found that the gastric tube could not pass through the kinked area.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.The root cause is manufacturing related.A capa was opened to address this issue.

Event Description

Reported event: after placement the user was unable to insert a stomach tube through the lma.Therefore, the lma was replaced with a new one.

• Brand Name: LMA SUPREME SIZE 3
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16327011
• MDR Text Key: 309487899
• Report Number: 9681900-2023-00002
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318082
• UDI-Public: 15060112318082
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

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 Operator: Health Professional
• Device Model Number: IPN922810
• Device Catalogue Number: 175030
• Device Lot Number: 11F22C0123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED