MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTHE

Model Number	IPN922876
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "we ordered a t5 autoclavable lma fastrach mask in march 2023 (put into service in the operating room in june 2023) which has only been autoclaved 3 times and whose balloon is leaking.".
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer.The manufacturer reported: "visual inspection on the complaint sample was reviewed, there was a tear on the pilot balloon area.Potentially, the user might mishandle the device during cleaning/autoclave.This device was no issue during usage (3 times).A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.The device worked for 3 times used before problem occurred.In ifu, there also caution to careful handling is essential due the lma fastrach is made of medical-grade silicone which can be torn or perforated.Always avoid contact with sharp or pointed objects.There is complaint conclude as unintentional user error related." teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported that "we ordered a t5 autoclavable lma fastrach mask in march 2023 (put into service in the operating room in june 2023) which has only been autoclaved 3 times and whose balloon is leaking.".

• Brand Name: LMA FASTRACH SIZE 5
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTHE
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18895003
• Report Number: 9681900-2024-00002
• Device Sequence Number: 7514739
• Product Code: CAE
• UDI-Device Identifier: 05060112310423
• UDI-Public: 05060112310423
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: 04/28/2025
• Device Model Number: IPN922876
• Device Catalogue Number: 130050
• Device Lot Number: UGAAWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown