MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Model Number	IPN922811
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "air leaked from the device during use on a patient.Therefore, it was replaced with a new unit".Specific information regarding the leak was not available.No patient harm or injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "complaint sample was received.No original product pouch was returned along with the complaint sample.The label print on the airway tube showed size 4 on the return lma supreme sample as per reported.Leak test was performed to the complaint sample.Presence of bubbles at joint between inflation balloon to check valve was observed.Visual inspection focusing on joining area (leakage) on current production lot (lma supreme): lot 11c22c0887 was performed.There was no abnormality was found.Dhr was reviewed.No abnormality was found." the complaint has been confirmed.The manufacturing site has determined that the root cause is manufacturing related.A non-conformance was opened to address this issue.
Event or Problem Description
It was reported that "air leaked from the device during use on a patient.Therefore, it was replaced with a new unit".Specific information regarding the leak was not available.No patient harm or injury reported.Patient condition reported as "fine".

• Brand Name: LMA SUPREME SIZE 4
• 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: 13710094
• Report Number: 9681900-2022-00010
• Device Sequence Number: 6362458
• Product Code: CAE
• UDI-Device Identifier: 15060112318099
• UDI-Public: 15060112318099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/14/2022

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
• Device Expiration Date: 06/28/2023
• Device Model Number: IPN922811
• Device Catalogue Number: 175040
• Device Lot Number: QMBNUG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2020
• 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