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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, tracheostomy (w/wo connector)
Regulation Description Tracheostomy tube and tube cuff.
Product CodeBTO
Regulation Number 868.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ERIE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 6
POSEY
  SUBSTANTIALLY EQUIVALENT 1
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 13
SMITHS
  SUBSTANTIALLY EQUIVALENT 2
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Air leak 346
Leak 91
Fracture 47
Break 39
Detachment of device component 30
Crack 28
Inflation issue 26
Deflation, cause unknown 20
Decrease in pressure 14
Component(s), broken 10
No Known Device Problem 10
Connection issue 7
Deflation issue 7
Hole in material 7
Replace 7
Material rupture 7
Fitting problem 7
Locking mechanism failure 7
Device, removal of (non-implant) 6
Material perforation 6
Device alarm system issue 6
Device operates differently than expected 6
Torn material 6
Unintended movement 6
Unknown (for use when the device problem is not known) 5
Split 5
Kinked 5
Tears, rips, holes in device, device material 5
Use of Device Issue 5
Difficult to remove 4
Sticking 4
Balloon leak(s) 4
Dislodged or dislocated 4
Detachment of device or device component 3
Material integrity issue 3
Burst 3
Balloon asymmetrical 3
Blockage within device or device component 3
Disconnection 3
Fluid leak 3
Difficult to insert 3
Loose or intermittent connection 3
Occlusion within device 3
Cut in material 3
Safety interlock(s) inadequate 3
Suction issue 3
Material separation 3
Improper or incorrect procedure or method 2
Slippage of device or device component 2
Tip breakage 2
Device damaged prior to use 2
Failure to disconnect 2
Physical resistance 2
Sharp/jagged/rough/etched/scratched 2
Malposition of device 2
Obstruction within device 2
Component or accessory incompatibility 2
Occlusion, incorrect 2
Material fragmentation 2
Bent 2
No code available 2
Difficult to advance 2
Manufacturing or shipping issue associated with device 2
Pressure issue 2
Scratched material 1
Material deformation 1
Infusion or flow issue 1
Device misassembled during manufacturing or shipping 1
Device handling issue 1
Naturally worn 1
Positioning Issue 1
Balloon rupture 1
Entrapment of device or device component 1
Restricted flowrate 1
Component incompatible 1
Design/structure problem 1
Installation error 1
Intraprocedure, fire or flash during 1
Peeled 1
Premature deployment 1
Device maintenance issue 1
Melted 1
Misassembled 1
Misconnection 1
Patient-device incompatibility 1
Device Issue 1
Structural problem 1
Other (for use when an appropriate device code cannot be identified) 1
Uncoiled 1
Size incorrect for patient 1
Material puncture 1
Reaction 1
Total Device Problems 891

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 0 1 1 0 0 0 0
Class II 0 0 2 0 2 1 0 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ambu Inc. II Mar-24-2016
2 Arcadia Medical Corporation II May-21-2012
3 Arcadia Medical Corporation II Jun-24-2011
4 Bryan Medical Inc I Jul-08-2013
5 Gf Health Products, Inc. II Nov-09-2009
6 Instrumentation Industries Inc II Nov-12-2015
7 Instrumentation Industries Inc II Sep-03-2009
8 Nellcor Puritan Bennett Inc. (dba Covidien Ltd) I May-06-2010
9 Smiths Medical ASD, Inc. I Jan-19-2012
10 VBM Medical Inc. II Jun-28-2011

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