MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 4

Model Number	IPN922801
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, "experienced a pressure leak, not good enough seal to maintain proper ventilation.The lma was removed as soon as doctor experienced the leak in the system, before desaturation.They removed the lma and inserted an ett.They were not monitoring the cuff pressure, but confirmed air in pilot balloon." no patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use on a patient, "experienced a pressure leak, not good enough seal to maintain proper ventilation.The lma was removed as soon as doctor experienced the leak in the system, before desaturation.They removed the lma and inserted an ett.They were not monitoring the cuff pressure, but confirmed air in pilot balloon." no patient harm or injury.The patient status is reported as "fine".

• Brand Name: LMA UNIQUE SIZE 4
• Common Device Name: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; 4 kamunting industrial estate; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17371783
• Report Number: 8040412-2023-00297
• Device Sequence Number: 15205973
• Product Code: CAE
• UDI-Device Identifier: 15060112318037
• UDI-Public: 15060112318037
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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: 01/06/2025
• Device Model Number: IPN922801
• Device Catalogue Number: 125040
• Device Lot Number: 11F22A0050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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