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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube tracheostomy and tube cuff
Regulation Description Tracheostomy tube and tube cuff.
Product CodeJOH
Regulation Number 868.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 15
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CONTINENTAL MEDICAL LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 4
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HELIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 10
MEDIKMARK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
PASSY-MUIR
  SUBSTANTIALLY EQUIVALENT 4
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
PREMIER
  SUBSTANTIALLY EQUIVALENT 1
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 3
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 5
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Air leak 746
Fluid leak 209
Detachment of device component 99
Leak 94
Fitting problem 76
Fracture 75
Break 71
Tears, rips, holes in device, device material 65
Component(s), broken 53
Inflation issue 49
Material deformation 39
Difficult to remove 32
Unknown (for use when the device problem is not known) 31
Connection issue 28
Material rupture 24
Hole in material 22
Deflation, cause unknown 19
Device Issue 18
No Known Device Problem 18
Deflation issue 16
Crack 15
Defective item 14
Other (for use when an appropriate device code cannot be identified) 12
Occlusion within device 12
Replace 11
Size incorrect for patient 10
Kinked 10
Balloon leak(s) 10
Cut in material 10
Device markings issue 10
Dislodged or dislocated 8
Sharp/jagged/rough/etched/scratched 8
Sticking 8
Material separation 8
Difficult to position 6
Alarm, audible 6
Difficult to insert 6
Failure to disconnect 6
Defective component 6
Wire(s), breakage of 5
Device operates differently than expected 5
Hose line occlusion 5
Deflation due to trauma 5
Disconnection 5
Balloon rupture 5
Interference 5
Shaft, split 4
Suction issue 4
Use of Device Issue 4
Component incompatible 4
Dislodged 4
Split 4
Material Protrusion 4
Torn material 3
Obstruction within device 3
Material perforation 3
Difficult to advance 3
Displacement 3
Material fragmentation 3
Loss of or failure to bond 3
Loose or intermittent connection 3
Method, improper/incorrect 2
Material discolored 2
Occlusion, incorrect 2
Device inoperable 2
Slippage of device or device component 2
Blockage within device or device component 2
Accessory incompatible 2
Balloon burst 2
Degraded 2
Detachment of device or device component 2
Device, removal of (non-implant) 2
Device displays error message 2
Malfunction 2
Positioning Issue 2
Mechanical jam 2
Material integrity issue 2
Incompatibility problem 2
Infusion or flow issue 2
No code available 2
Device handling issue 1
Manufacturing or shipping issue associated with device 1
Mechanics altered 1
Material twisted 1
Pressure issue 1
Protective measure issue 1
Scratched material 1
Unintended movement 1
No Information 1
Packaging issue 1
Tear, rip or hole in device packaging 1
Tube(s), defective 1
Component missing 1
Residue after decontamination 1
Tube(s), buckling of 1
Locking mechanism failure 1
Deployment issue 1
Malposition of device 1
Application program issue 1
Disinfection or Sterilization Issue at User Location 1
Total Device Problems 2105

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

Recalls
Manufacturer Recall Class Date Posted
1 Cook, Inc. I Jul-26-2010
2 Covidien LP (formerly Nellcor Puritan Bennett Inc.) I Jul-09-2015
3 Covidien Limited I Mar-04-2009
4 Customed, Inc II Mar-21-2012
5 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Aug-10-2012
6 Nellcor Puritan Bennett Inc. (dba Covidien Ltd) I May-06-2010
7 Smiths Medical ASD, Inc. II Nov-07-2007
8 Smiths Medical ASD, Inc. II Jan-05-2007
9 Teleflex Medical II Jun-29-2011

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