• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Inflation Problem 899
Leak/Splash 460
Gas Leak 403
Use of Device Problem 295
Cuff 229
Disconnection 221
Air Leak 206
Device Contamination with Chemical or Other Material 199
Defective Component 154
Detachment of Device or Device Component 151
Device Markings/Labelling Problem 111
Tube 101
Deflation Problem 100
Break 98
Connection Problem 97
Material Deformation 87
Loose or Intermittent Connection 72
Material Split, Cut or Torn 69
Device Operates Differently Than Expected 67
Material Separation 67
Kinked 60
Pressure Problem 56
Material Puncture/Hole 54
Material Integrity Problem 48
Detachment Of Device Component 47
Insufficient Information 44
Obstruction of Flow 42
Appropriate Term/Code Not Available 41
Occlusion Within Device 40
Material Rupture 37
Human-Device Interface Problem 36
Contamination /Decontamination Problem 35
Balloon 34
Partial Blockage 32
Crack 31
Burst Container or Vessel 30
Contamination 29
Adverse Event Without Identified Device or Use Problem 28
Device Packaging Compromised 27
Fitting Problem 26
Deformation Due to Compressive Stress 25
Contamination of Device Ingredient or Reagent 25
Inadequate Instructions for Healthcare Professional 22
Difficult to Advance 21
Material Twisted/Bent 21
Hole In Material 21
Fracture 19
Connector 19
Inadequacy of Device Shape and/or Size 19
Packaging Problem 18
Pilot Balloon Valve 17
Bent 17
Component Missing 16
Malposition of Device 16
Decrease in Pressure 15
Fluid Leak 15
Material Too Rigid or Stiff 14
Defective Device 13
Mechanical Problem 13
Torn Material 13
Material Fragmentation 13
Device Damaged Prior to Use 13
Difficult to Insert 11
Failure to Disconnect 11
Tear, Rip or Hole in Device Packaging 11
Delivered as Unsterile Product 10
Product Quality Problem 10
Unsealed Device Packaging 10
Device Alarm System 9
Peeled/Delaminated 9
Split 8
Ejection Problem 8
System 8
Labelling, Instructions for Use or Training Problem 8
Material Perforation 7
Device Dislodged or Dislocated 7
Flange 7
Unraveled Material 6
Cannula 6
Manufacturing, Packaging or Shipping Problem 6
Delamination 5
Valve(s) 5
Patient Device Interaction Problem 5
Physical Resistance 5
Cut In Material 4
False Alarm 4
Stylet 4
Nonstandard Device 4
Separation Failure 4
Infusion or Flow Problem 4
Off-Label Use 4
Suction Problem 4
Collapse 4
Device-Device Incompatibility 4
Output Problem 3
Device Operational Issue 3
Alarm 3
Joint 3
Probe 3
Material Protrusion/Extrusion 3
Total Device Problems 5478

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 INC II Jul-10-2020
5 Teleflex Medical I Sep-09-2019
6 Teleflex Medical I Jun-19-2019
7 Teleflex Medical II May-29-2019
8 Teleflex Medical II Feb-09-2017
9 Teleflex Medical II Nov-09-2016
10 Teleflex Medical II Jun-09-2016
11 Teleflex Medical II Feb-10-2015
12 Teleflex, Inc. II Feb-17-2015

-
-