MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3

Model Number	IPN922810
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor found cuff leakage when using on patient and changed new one".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found cuff leakage when using on patient and changed new one".No patient injury or harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported that "the doctor found cuff leakage when using on patient and changed new one".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "the complaint sample was tested; it could not hold inflation during the test.Another test was performed on the sample and air leak was observed when it was immersed in the water." a device history record review was performed and no relevant findings were identified.Based on the investigation performed, the complaint was confirmed.The root cause was deemed manufacturing related.A capa was opened to further address this issue.

• 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: 13534696
• Report Number: 9681900-2022-00008
• Device Sequence Number: 4039426
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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: 12/28/2022
• Device Model Number: IPN922810
• Device Catalogue Number: 175030
• Device Lot Number: PMDKGA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2020
• 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