MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3

Catalog Number 175030

Device Problem Gas/Air Leak (2946)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A photo was received and confirmed the product was lma supreme.There was no specific area shown on the photo of the device leak.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a.Corrected data:.

Event Description

It was reported that "the doctor found cuff leakage when doing clinical setting before using on patient.Then changed new one, no impact on patient.".

Manufacturer Narrative

(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "leak test was performed to the complaint sample.During the leak test there was presence of bubble was identified on the cuff and joint area of the device.Review on the leaking area, the was small hole at the gluing area on cuff to backplate.During reviewed on gluing process for cuff to backplate as per opwi 202-02-24 rev14 lma supreme cawt line, under step 4 there is no potential cause that could lead same type of defect.During simulation for the gluing process and purposely roughly rubbing/scratching on the cuff surface also could not create the same defect.Even punching the cuff surface using the needle not having the same defect.Dhr for the packaging lot 11f2200197 was reviewed and found no abnormalities with the complaint lot.Reviewed on manufacturing process and testing was conducted to simulate defect complaint received, there was no similar process that can be led to defect type.Since there was no clear evident the defect could occur at manufacturing site, for worst case the root cause still considered as manufacturing related.".A capa was opened to address this issue.

Event Description

It was reported that "the doctor found cuff leakage when doing clinical setting before using on patient.Then changed new one, no impact on patient.".

• 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
• MDR Report Key: 16752693
• MDR Text Key: 313436179
• Report Number: 9681900-2023-00013
• Device Sequence Number: 1
• Product Code: CAE
• 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: 03/23/2023

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 Catalogue Number: 175030
• Device Lot Number: 11F22D0197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2022
• 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