Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH COMBO-KIT, SU, SIZE 4; LMA FASTRACH (SU)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL LMA FASTRACH COMBO-KIT, SU, SIZE 4; LMA FASTRACH (SU) Back to Search Results
Model Number IPN042411
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "experiencing difficulty inserting et tubes into lma fastrachs.The et tubes are always lubricated, but still tend to get hung up on something inside of the lma fastrachs".No patient involvement reported.
 
Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as it was reported that the sample is not available for return.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
It was reported "experiencing difficulty inserting et tubes into lma fastrachs.The et tubes are always lubricated, but still tend to get hung up on something inside of the lma fastrachs".No patient involvement reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LMA FASTRACH COMBO-KIT, SU, SIZE 4
Type of Device
LMA FASTRACH (SU)
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key11235993
MDR Text Key228884880
Report Number3004365956-2021-00022
Device Sequence Number1
Product Code CAE
UDI-Device Identifier05060112311895
UDI-Public05060112311895
Combination Product (y/n)N
PMA/PMN Number
K051993
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 01/07/2021
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 Model NumberIPN042411
Device Catalogue Number135240
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/07/2021
Initial Date FDA Received01/27/2021
Supplement Dates Manufacturer Received02/11/2021
Supplement Dates FDA Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-