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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH, SU, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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TELEFLEX MEDICAL LMA FASTRACH, SU, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 135140
Device Problem Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complain is still in progress.
 
Event Description
Customer complaint alleges "during procedure the doctor could not position a endotracheal tube gr.6.5 single use trough the fastrach".Alleged issue reported as occurred during use.It was reported another device was obtained for use.There was no report of patient harm.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).The et tube involved in the complaint was not returned along with the lma fastrach su device.A visual exam was performed on the returned sample and the outer profile looked standard and normal upon receipt.There was no physical damage observed.In addition there was no significant difference in shape when it was compared to a sample at the manufacturing site.The returned device could also be inflated and deflated normally.A retained sample of an et tube (size 6.5) was lubricated and it was able to pass through the returned device with no issues.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.
 
Event Description
Customer complaint alleges "during procedure the doctor could not position a endotracheal tube gr.6.5 single use trough the fastrach".Alleged issue reported as occurred during use.It was reported another device was obtained for use.There was no report of patient harm.Patient condition reported as "fine".
 
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Brand Name
LMA FASTRACH, SU, SIZE 4
Type of Device
AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key7350612
MDR Text Key102873607
Report Number9681900-2018-00021
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/28/2018
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 Catalogue Number135140
Device Lot NumberKPABLN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2018
Initial Date Manufacturer Received 02/28/2018
Initial Date FDA Received03/19/2018
Supplement Dates Manufacturer Received04/12/2018
Supplement Dates FDA Received04/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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