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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stylet, tracheal tube
Regulation Description Tracheal tube stylet.
Product CodeBSR
Regulation Number 868.5790
Device Class 1


Premarket Reviews
ManufacturerDecision
AUGUSTINE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 3
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LAERDAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material fragmentation 24
Break 19
Detachment of device component 9
Failure to Adhere or Bond 8
Material separation 6
Difficult to insert 4
Misassembled 4
Crack 3
Detachment of device or device component 3
Device markings issue 3
Sticking 2
Tip breakage 2
Foreign material present in device 2
No Known Device Problem 2
Device handling issue 2
Occlusion within device 2
Fracture 2
Air leak 1
Markings unclear 1
Material puncture 1
Difficult to remove 1
Replace 1
Retraction problem 1
Material rigid or stiff 1
Fiberoptic break/separation 1
Flaked 1
Bent 1
Component(s), broken 1
No Information 1
No code available 1
Suction issue 1
Cut in material 1
Failure to disconnect 1
Defective item 1
Difficult to advance 1
Shelf life exceeded 1
Source, detachment from 1
Total Device Problems 117

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 1 0 0 3 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Feb-04-2015
2 Teleflex Medical II Nov-06-2015
3 Teleflex Medical II Jan-11-2012
4 Vital Signs Colorado Inc. II Apr-30-2015
5 Vital Signs Colorado Inc. II Sep-21-2008

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