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 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the doctor found cuff leakage during clinical setting before using on patient".No patient involvement reported.

Manufacturer Narrative

(b)(4).The actual sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports functional testing was performed and there were no issues with inflation and deflation of the device.There was no sign of an air leak observed, and when the device was submerged in water there were no air bubbles escaping from the device.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the complaint could not be confirmed.The device was able to be deflated and inflated normally.There was no air leak observed when the cuff was inflated.The device functioned as intended.

Event Description

It was reported that "the doctor found cuff leakage during clinical setting before using on patient".No patient involvement reported.

• 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: 12787847
• MDR Text Key: 281522501
• Report Number: 9681900-2021-00036
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318082
• UDI-Public: 15060112318082
• 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: 10/18/2021

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: 10/28/2022
• Device Catalogue Number: 175030
• Device Lot Number: PMCVU9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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