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 11/12/2021

Event Type  malfunction  

Event Description

It was reported that "the doctor found cuff leakage when using on patient and then changed new one".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: the complaint description is related to cuff leakage during use.Based on the complaint sample returned from customer, the sample was able to be deflated and inflated normally.There was no air leak observed when the sample was inflated.The sample was also immersed into water for air leak test; there was no air leak observed from the device.From the returned complaint sample, no air leak was verified.The root cause was classified as "no problem found".".

Event Description

It was reported that "the doctor found cuff leakage when using on patient and then changed new one".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: LMA SUPREME SIZE 4
• 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: 12939324
• MDR Text Key: 283148153
• Report Number: 9681900-2021-00049
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318099
• UDI-Public: 15060112318099
• 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: 11/16/2021

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 Expiration Date: 05/28/2023
• Device Catalogue Number: 175040
• Device Lot Number: QMBCP5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 12/30/2021
• Supplement Dates FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• 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