TPLC - Total Product Life Cycle

• Device: tube, tracheal (w/wo connector)
• Regulation Description: Tracheal tube.
• Product Code: BTR
• Regulation Number: 868.5730
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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