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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, tracheal (w/wo connector)
Regulation Description Tracheal tube.
Product CodeBTR
Regulation Number 868.5730
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DAVIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ETVIEW LTD.
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Inflation Problem 876
Leak / Splash 426
Cuff 220
Gas Leak 208
Air Leak 206
Disconnection 203
Device Contamination with Chemical or Other Material 199
Use of Device Problem 158
Detachment of Device or device Component 145
Defective Component 125
Device Markings / Labelling Problem 108
Tube 99
Deflation Problem 96
Break 94
Connection Problem 82
Material Deformation 76
Loose or Intermittent Connection 71
Device Operates Differently Than Expected 67
Material Separation 61
Kinked 60
Detachment Of Device Component 47
Material Split, Cut or Torn 46
Material Puncture / Hole 43
Occlusion Within Device 40
Obstruction of Flow 39
Insufficient Information 37
Human-Device Interface Problem 36
Pressure Problem 36
Appropriate Term/Code Not Available 35
Material Rupture 35
Material Integrity Problem 33
Contamination / decontamination Problem 33
Partial Blockage 32
Balloon 30
Contamination During Use 29
Adverse Event Without Identified Device or Use Problem 27
Device Packaging Compromised 27
Burst Container or Vessel 26
Fitting Problem 26
Contamination of Device Ingredient or Reagent 25
Crack 23
Inadequate Instructions for Healthcare Professional 22
Deformation Due to Compressive Stress 21
Difficult to Advance 21
Hole In Material 21
Connector 19
Packaging Problem 18
Bent 17
Fracture 17
Component Missing 16
Pilot Balloon Valve 16
Inadequacy of Device Shape and/or Size 16
Malposition of device 15
Decrease in Pressure 15
Material Too Rigid or Stiff 14
Defective Device 13
Torn Material 13
Device Damaged Prior to Use 13
Material Fragmentation 11
Failure to Disconnect 11
Mechanical Problem 10
Delivered as Unsterile Product 10
Tear, Rip or Hole in Device Packaging 10
Fluid Leak 10
Material Twisted / Bent 10
Difficult to Insert 10
Unsealed Device Packaging 10
Product Quality Problem 9
Device Alarm System 9
Peeled / Delaminated 8
Split 8
Ejection Problem 8
Flange 8
System 8
Material Perforation 7
Device Dislodged or Dislocated 7
Unraveled Material 6
Cannula 6
Manufacturing, Packaging or Shipping Problem 5
Delamination 5
Valve 5
Physical Resistance 5
Cut In Material 4
Patient Device Interaction Problem 4
False Alarm 4
Stylet 4
Nonstandard device 4
Separation Failure 4
Infusion or Flow Problem 4
Device-Device Incompatibility 4
Off-Label Use 4
Suction Problem 4
Collapse 3
Output Problem 3
Alarm 3
Device Operational Issue 3
Joint 3
Probe 3
Material Protrusion / Extrusion 3
Ventilation Problem in Device Environment 3
Total Device Problems 4832

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation I Jul-30-2019
2 Parker Medical II Jul-19-2016
3 Stryker Sustainability Solutions II May-09-2016
4 Teleflex Medical I Sep-09-2019
5 Teleflex Medical I Jun-19-2019
6 Teleflex Medical II May-29-2019
7 Teleflex Medical II Feb-09-2017
8 Teleflex Medical II Nov-09-2016
9 Teleflex Medical II Jun-09-2016
10 Teleflex Medical II Feb-10-2015
11 Teleflex, Inc. II Feb-17-2015

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