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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL LMA FASTRACH, SU, SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 135150
Device Problem Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2018
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.A follow up report will be sent at the the conclusion of the investigation.
 
Event Description
Customer complaint alleges "when the staff tried to insert the tube in the mask (size 5), the tube got stuck on the mask.The staff tried with a mask size 4, and the intubation was performed properly." customer reported a delay in intubation.There was no report of patient injury or complication.The patient condition was reported as "fine".
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.
 
Event Description
Customer complaint alleges "when the staff tried to insert the tube in the mask (size 5), the tube got stuck on the mask.The staff tried with a mask size 4, and the intubation was performed properly." customer reported a delay in intubation.There was no report of patient injury or complication.The patient condition was reported as "fine".
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.
 
Event Description
Customer complaint alleges "when the staff tried to insert the tube in the mask (size 5), the tube got stuck on the mask.The staff tried with a mask size 4, and the intubation was performed properly." customer reported a delay in intubation.There was no report of patient injury or complication.The patient condition was reported as "fine".
 
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Brand Name
LMA FASTRACH, SU, SIZE 5
Type of Device
AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key7628613
MDR Text Key111986292
Report Number9681900-2018-00030
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 06/07/2018
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 No Information
Device Expiration Date03/28/2019
Device Catalogue Number135150
Device Lot NumberLPAAQD
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/07/2018
Initial Date FDA Received06/22/2018
Supplement Dates Manufacturer Received07/04/2018
Supplement Dates FDA Received07/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FASTRACH ETT 136080; FASTRACH ETT 136080; FASTRACH ETT 136080
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