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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTHE
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TELEFLEX MEDICAL LMA FASTRACH SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTHE Back to Search Results
Model Number IPN922876
Device Problem Gas/Air Leak (2946)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event 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.".
 
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 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.".
 
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Brand Name
LMA FASTRACH SIZE 5
Type of Device
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 Key18895003
MDR Text Key337666865
Report Number9681900-2024-00002
Device Sequence Number1
Product Code CAE
UDI-Device Identifier05060112310423
UDI-Public05060112310423
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Model NumberIPN922876
Device Catalogue Number130050
Device Lot NumberUGAAWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/16/2024
Initial Date FDA Received03/13/2024
Supplement Dates Manufacturer Received04/04/2024
Supplement Dates FDA Received04/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED.; NOT REPORTED.
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