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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 4
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 115
Deflation, cause unknown 20
Detachment of device component 10
Break 8
Replace 7
Locking mechanism failure 6
Device, removal of (non-implant) 6
Tears, rips, holes in device, device material 5
Fitting problem 4
Balloon leak(s) 4
Crack 3
Balloon asymmetrical 3
Use of Device Issue 3
Component(s), broken 2
Device damaged prior to use 2
Sharp/jagged/rough/etched/scratched 2
Sticking 2
Tip breakage 2
Occlusion, incorrect 2
Blockage within device or device component 2
Device misassembled during manufacturing or shipping 1
Size incorrect for patient 1
Leak 1
Device maintenance issue 1
Uncoiled 1
Device Issue 1
Design/structure problem 1
Hole in material 1
Difficult to remove 1
Material separation 1
Entrapment of device or device component 1
Restricted flowrate 1
Difficult to insert 1
Kinked 1
Reaction 1
Balloon rupture 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Detachment of device or device component 1
Installation error 1
Material puncture 1
Total Device Problems 229

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 1 0 1 0
Class II 0 0 2 0 2 1 0
Class III 0 0 0 0 0 0 0

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

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