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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 313
Leak 68
Fracture 44
Break 30
Detachment of device component 29
Crack 23
Deflation, cause unknown 20
Inflation issue 13
Component(s), broken 10
No Known Device Problem 10
Connection issue 7
Hole in material 7
Decrease in pressure 7
Replace 7
Locking mechanism failure 7
Device, removal of (non-implant) 6
Fitting problem 6
Unknown (for use when the device problem is not known) 5
Split 5
Material rupture 5
Kinked 5
Tears, rips, holes in device, device material 5
Use of Device Issue 5
Deflation issue 5
Unintended movement 5
Device operates differently than expected 4
Balloon leak(s) 4
Burst 3
Balloon asymmetrical 3
Blockage within device or device component 3
Disconnection 3
Fluid leak 3
Occlusion within device 3
Safety interlock(s) inadequate 3
Suction issue 3
Material separation 3
Sticking 3
Dislodged or dislocated 3
Torn material 3
Pressure issue 2
No code available 2
Difficult to advance 2
Detachment of device or device component 2
Component or accessory incompatibility 2
Failure to disconnect 2
Sharp/jagged/rough/etched/scratched 2
Material perforation 2
Device damaged prior to use 2
Obstruction within device 2
Improper or incorrect procedure or method 2
Tip breakage 2
Difficult to remove 2
Slippage of device or device component 2
Occlusion, incorrect 2
Loose or intermittent connection 2
Material fragmentation 2
Difficult to insert 2
Bent 2
Device alarm system issue 2
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
Device maintenance issue 1
Melted 1
Peeled 1
Premature deployment 1
Uncoiled 1
Size incorrect for patient 1
Material puncture 1
Reaction 1
Cut in material 1
Structural problem 1
Other (for use when an appropriate device code cannot be identified) 1
Device Issue 1
Physical resistance 1
Malposition of device 1
Patient-device incompatibility 1
Device misassembled during manufacturing or shipping 1
Infusion or flow issue 1
Naturally worn 1
Positioning Issue 1
Total Device Problems 757

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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