MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3

Catalog Number	175030
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor found cuff leakage during clinical setting before using on patient".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).
Additional 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 or Problem 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
• Common Device Name: 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: 12787345
• Report Number: 9681900-2021-00042
• Device Sequence Number: 4840259
• Product Code: CAE
• UDI-Device Identifier: 15060112318082
• UDI-Public: 15060112318082
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown