MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3

Model Number IPN902070

Device Problem Nonstandard Device (1420)

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

Event Date 01/18/2023

Event Type  malfunction  

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

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 c omplaint 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: 16380437
• MDR Text Key: 309600107
• Report Number: 9681900-2023-00004
• 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
• Treatment: NONE REPORTED.; NONE REPORTED.