MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 3

Model Number	IPN922800
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: the cuff was leaking.Another device was used.
Additional Manufacturer Narrative
Qn# (b)(4).The returned device size was the same as the complaint description.Review on the product appearance showed no abnormality such as a tear, burst, or rear at the cuff or joint.A leak test was performed and there was no presence of bubble on the cuff or joint area.A second flow leak test was performed to ensure there was no leak identified at gluing area or cuff to backplate and airway tube to backplate.There was no leak found.The device history review for lot 11f22c0205 was reviewed and there was no nc for that lot during production.No corrective action is required at this time.The root cause was identified as no problem found on the sample.

• Brand Name: LMA UNIQUE SIZE 3
• Common Device Name: LMA UNIQUE
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16569551
• Report Number: 9681900-2023-00010
• Device Sequence Number: 20368049
• Product Code: CAE
• UDI-Device Identifier: 15060112318112
• UDI-Public: 15060112318112
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

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: 03/18/2025
• Device Model Number: IPN922800
• Device Catalogue Number: 125030
• Device Lot Number: 11F22C0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown