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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 782
Fluid leak 226
Leak 203
Break 149
Inflation issue 128
Detachment of device component 109
Fitting problem 77
Fracture 75
Tears, rips, holes in device, device material 65
Hole in material 56
Component(s), broken 53
Material deformation 49
Material integrity issue 47
Connection issue 35
Difficult to remove 35
Material rupture 34
Split 33
Unknown (for use when the device problem is not known) 31
Deflation issue 26
No Known Device Problem 22
Defective item 21
Crack 19
Deflation, cause unknown 19
Device Issue 18
Cut in material 14
Device markings issue 14
Size incorrect for patient 13
Occlusion within device 13
Dislodged or dislocated 12
Material perforation 12
Other (for use when an appropriate device code cannot be identified) 12
Torn material 12
Defective component 11
Material separation 11
Replace 11
Kinked 11
Disconnection 10
Balloon leak(s) 10
Device operates differently than expected 9
Sharp/jagged/rough/etched/scratched 8
Patient-device incompatibility 8
Manufacturing or shipping issue associated with device 8
Sticking 8
Obstruction within device 8
Mechanical issue 8
Difficult to insert 7
Product quality issue 7
Loose or intermittent connection 7
Difficult to position 7
Burst 7
Device alarm system issue 7
Naturally worn 7
Packaging issue 7
Human-Device Interface Issue 7
Infusion or flow issue 6
Failure to disconnect 6
Use of Device Issue 6
Suction issue 6
Alarm, audible 6
Loss of or failure to bond 6
Material fragmentation 6
No Information 6
Hose line occlusion 5
Interference 5
Balloon rupture 5
Deflation due to trauma 5
Wire(s), breakage of 5
Detachment of device or device component 5
Difficult to advance 5
Material Protrusion 4
Buckled material 4
Out-of-box failure 4
Component incompatible 4
Dislodged 4
Shaft, split 4
Displacement 3
Material discolored 3
Blockage within device or device component 3
Positioning Issue 3
No code available 3
Scratched material 3
Mechanical jam 2
Incompatibility problem 2
Device, removal of (non-implant) 2
Component missing 2
Device displays error message 2
Malfunction 2
Failure to advance 2
Device inoperable 2
Bent 2
Collapse 2
Accessory incompatible 2
Balloon burst 2
Degraded 2
Slippage of device or device component 2
Peeled 2
Material rigid or stiff 2
Occlusion, incorrect 2
Method, improper/incorrect 2
Misapplication 1
Total Device Problems 2760

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 2
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 Sep-26-2017
8 Smiths Medical ASD Inc. II Mar-14-2017
9 Smiths Medical ASD, Inc. II Nov-07-2007
10 Smiths Medical ASD, Inc. II Jan-05-2007
11 Teleflex Medical I Oct-18-2016
12 Teleflex Medical II Jun-29-2011

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