MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3

Model Number IPN902070

Device Problem Fitting Problem (2183)

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

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.(associated report 9 681900-2023-00004).

Event Description

Reported event: during a resuscitation, a 50cc luer-lock failed to attach to the lma.A new lma size 3 was used and was able to attach a 50cc luer-lock.After the procedure another device was tested with a luer-lock 50cc and this also failed to fit.

Event Description

Reported event: during a resuscitation, a 50cc luer-lock failed to attach to the lma.A new lma size 3 was used and was able to attach a 50cc luer-lock.After the procedure another device was tested with a luer-lock 50cc and this also failed to fit.

Manufacturer Narrative

(b)(4).No actual sample received for further investigation.Based on the complaint description of "luer connector not fitting during test / use", reviewing of the device history of the packaging and assembly lot, reviewing the nc list, it was concluded that the complaint root cause is undetermined/unknown as the assembly or packaging process for the affected lot manufacturing process did not have any record on the similar issue.Further investigation shall be performed once the complaint sample was returned to kulim.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16382679
• MDR Text Key: 309640640
• Report Number: 9681900-2023-00003
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318082
• UDI-Public: 15060112318082
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/19/2023

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: IPN902070
• Device Catalogue Number: 175030
• Device Lot Number: 11F21G0114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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