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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 755
Fluid leak 212
Leak 170
Break 122
Detachment of device component 108
Fitting problem 76
Fracture 75
Tears, rips, holes in device, device material 65
Inflation issue 64
Component(s), broken 53
Material deformation 42
Hole in material 34
Difficult to remove 34
Unknown (for use when the device problem is not known) 31
Connection issue 31
Material rupture 30
Split 23
No Known Device Problem 21
Deflation, cause unknown 19
Deflation issue 19
Device Issue 18
Material integrity issue 17
Crack 16
Defective item 14
Cut in material 13
Other (for use when an appropriate device code cannot be identified) 12
Occlusion within device 12
Material separation 11
Replace 11
Kinked 10
Size incorrect for patient 10
Balloon leak(s) 10
Defective component 10
Device markings issue 10
Dislodged or dislocated 10
Torn material 9
Disconnection 9
Sticking 8
Sharp/jagged/rough/etched/scratched 8
Material perforation 7
Loose or intermittent connection 7
Difficult to insert 6
Difficult to position 6
Loss of or failure to bond 6
Alarm, audible 6
Device alarm system issue 6
Suction issue 6
Failure to disconnect 6
Patient-device incompatibility 6
Obstruction within device 5
Wire(s), breakage of 5
Device operates differently than expected 5
Balloon rupture 5
Deflation due to trauma 5
Interference 5
Use of Device Issue 5
Hose line occlusion 5
Shaft, split 4
Component incompatible 4
Dislodged 4
Detachment of device or device component 4
Difficult to advance 4
Material Protrusion 4
Out-of-box failure 4
No Information 3
No code available 3
Displacement 3
Material fragmentation 3
Material discolored 3
Burst 3
Product quality issue 3
Slippage of device or device component 2
Occlusion, incorrect 2
Method, improper/incorrect 2
Collapse 2
Blockage within device or device component 2
Accessory incompatible 2
Balloon burst 2
Degraded 2
Positioning Issue 2
Incompatibility problem 2
Infusion or flow issue 2
Mechanical jam 2
Malfunction 2
Device inoperable 2
Device, removal of (non-implant) 2
Device displays error message 2
Locking mechanism failure 1
Malposition of device 1
Application program issue 1
Buckled material 1
Disinfection or Sterilization Issue at User Location 1
Component or accessory incompatibility 1
Device misassembled during manufacturing or shipping 1
Deployment issue 1
Tidal volume fluctuations 1
Tube(s), splitting of 1
Tear, rip or hole in device packaging 1
Residue after decontamination 1
Tube(s), buckling of 1
Total Device Problems 2398

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 1 2 0 1 0 0 1 1 0
Class II 2 0 0 0 1 1 0 0 0 0 1
Class III 0 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 Mar-14-2017
8 Smiths Medical ASD, Inc. II Nov-07-2007
9 Smiths Medical ASD, Inc. II Jan-05-2007
10 Teleflex Medical I Oct-18-2016
11 Teleflex Medical II Jun-29-2011

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