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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 206
Detachment of device component 98
Fitting problem 73
Fracture 70
Leak 69
Tears, rips, holes in device, device material 65
Break 63
Component(s), broken 53
Inflation issue 48
Material deformation 39
Difficult to remove 32
Unknown (for use when the device problem is not known) 31
Connection issue 26
Material rupture 23
Hole in material 19
Deflation, cause unknown 19
Device Issue 18
No Known Device Problem 18
Deflation issue 16
Defective item 14
Crack 13
Other (for use when an appropriate device code cannot be identified) 12
Occlusion within device 12
Replace 11
Kinked 10
Size incorrect for patient 10
Balloon leak(s) 10
Cut in material 10
Device markings issue 10
Sharp/jagged/rough/etched/scratched 8
Dislodged or dislocated 8
Sticking 8
Material separation 7
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
Use of Device Issue 4
Shaft, split 4
Component incompatible 4
Dislodged 4
Suction issue 4
Split 4
Material Protrusion 4
Torn material 3
Obstruction within device 3
Material perforation 3
Displacement 3
Material fragmentation 3
Loss of or failure to bond 3
Loose or intermittent connection 3
Method, improper/incorrect 2
Occlusion, incorrect 2
Slippage of device or device component 2
Device inoperable 2
Blockage within device or device component 2
Accessory incompatible 2
Balloon burst 2
Degraded 2
Device displays error message 2
Malfunction 2
Detachment of device or device component 2
Difficult to advance 2
Incompatibility problem 2
Device, removal of (non-implant) 2
Positioning Issue 2
No code available 2
Mechanical jam 2
Mechanics altered 1
Packaging issue 1
Material twisted 1
Material integrity issue 1
Device handling issue 1
Pressure issue 1
Scratched material 1
Unintended movement 1
No Information 1
Malposition of device 1
Application program issue 1
Disinfection or Sterilization Issue at User Location 1
Device misassembled during manufacturing or shipping 1
Deployment issue 1
Infusion or flow issue 1
Manufacturing or shipping issue associated with device 1
Improper device output 1
Inadequate user interface 1
Device packaging compromised 1
Device-device incompatibility 1
Locking mechanism failure 1
Tube(s), defective 1
Component missing 1
Total Device Problems 2046

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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