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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 749
Fluid leak 211
Leak 116
Detachment of device component 103
Break 94
Fitting problem 76
Fracture 75
Tears, rips, holes in device, device material 65
Component(s), broken 53
Inflation issue 50
Material deformation 39
Difficult to remove 34
Unknown (for use when the device problem is not known) 31
Connection issue 31
Hole in material 25
Material rupture 24
No Known Device Problem 20
Deflation, cause unknown 19
Deflation issue 18
Device Issue 18
Split 17
Crack 15
Defective item 14
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
Cut in material 10
Device markings issue 10
Sharp/jagged/rough/etched/scratched 8
Dislodged or dislocated 8
Sticking 8
Defective component 7
Difficult to position 6
Material perforation 6
Suction issue 6
Failure to disconnect 6
Difficult to insert 6
Loss of or failure to bond 6
Alarm, audible 6
Disconnection 6
Deflation due to trauma 5
Balloon rupture 5
Hose line occlusion 5
Interference 5
Device operates differently than expected 5
Wire(s), breakage of 5
Obstruction within device 5
Torn material 5
Difficult to advance 4
Material integrity issue 4
Material Protrusion 4
Shaft, split 4
Use of Device Issue 4
Device alarm system issue 4
Component incompatible 4
Dislodged 4
Displacement 3
Material fragmentation 3
Loose or intermittent connection 3
No Information 3
No code available 2
Incompatibility problem 2
Infusion or flow issue 2
Mechanical jam 2
Positioning Issue 2
Malfunction 2
Device inoperable 2
Detachment of device or device component 2
Device displays error message 2
Device, removal of (non-implant) 2
Method, improper/incorrect 2
Occlusion, incorrect 2
Slippage of device or device component 2
Material discolored 2
Degraded 2
Accessory incompatible 2
Balloon burst 2
Blockage within device or device component 2
Collapse 2
Coiled 1
Balloon mushroomed 1
Balloon asymmetrical 1
Aspiration, excessive 1
Failure to deploy 1
Material frayed 1
Difficult to flush 1
Foreign material 1
Electrical issue 1
Entrapment of device or device component 1
Restricted flowrate 1
Material rigid or stiff 1
Valve(s), failure of 1
Volume accuracy issue 1
Improper or incorrect procedure or method 1
Increase in suction 1
Tidal volume fluctuations 1
Total Device Problems 2211

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 2 0 1 0 0 1 1
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 I Oct-18-2016
10 Teleflex Medical II Jun-29-2011

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