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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 765
Fluid leak 219
Leak 190
Break 133
Detachment of device component 108
Inflation issue 93
Fitting problem 76
Fracture 75
Tears, rips, holes in device, device material 65
Component(s), broken 53
Material deformation 48
Hole in material 45
Difficult to remove 35
Material rupture 33
Unknown (for use when the device problem is not known) 31
Connection issue 31
Material integrity issue 27
Split 24
No Known Device Problem 22
Deflation, cause unknown 19
Deflation issue 19
Device Issue 18
Defective item 17
Crack 16
Cut in material 13
Device markings issue 13
Dislodged or dislocated 12
Material perforation 12
Other (for use when an appropriate device code cannot be identified) 12
Size incorrect for patient 12
Occlusion within device 12
Material separation 11
Replace 11
Kinked 11
Defective component 11
Torn material 11
Balloon leak(s) 10
Disconnection 9
Sticking 8
Sharp/jagged/rough/etched/scratched 8
Patient-device incompatibility 8
Product quality issue 7
Device operates differently than expected 7
Difficult to insert 7
Loose or intermittent connection 7
Device alarm system issue 7
Alarm, audible 6
Loss of or failure to bond 6
Use of Device Issue 6
Difficult to position 6
Infusion or flow issue 6
No Information 6
Suction issue 6
Failure to disconnect 6
Obstruction within device 5
Detachment of device or device component 5
Wire(s), breakage of 5
Packaging issue 5
Interference 5
Hose line occlusion 5
Balloon rupture 5
Deflation due to trauma 5
Component incompatible 4
Dislodged 4
Material fragmentation 4
Burst 4
Shaft, split 4
Manufacturing or shipping issue associated with device 4
Difficult to advance 4
Material Protrusion 4
Out-of-box failure 4
Buckled material 3
No code available 3
Scratched material 3
Material discolored 3
Displacement 3
Degraded 2
Collapse 2
Bent 2
Blockage within device or device component 2
Accessory incompatible 2
Balloon burst 2
Occlusion, incorrect 2
Method, improper/incorrect 2
Slippage of device or device component 2
Positioning Issue 2
Mechanical jam 2
Incompatibility problem 2
Failure to advance 2
Device, removal of (non-implant) 2
Device displays error message 2
Component missing 2
Malfunction 2
Device inoperable 2
Tube(s), defective 1
Tear, rip or hole in device packaging 1
Residue after decontamination 1
Tube(s), buckling of 1
Locking mechanism failure 1
Malposition of device 1
Total Device Problems 2562

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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