TPLC - Total Product Life Cycle

• Device: tube, tracheal/bronchial, differential ventilation (w/wo connector)
• Regulation Description: Tracheal/bronchial differential ventilation tube.
• Product Code: CBI
• Regulation Number: 868.5740
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	5
KENDALL
	SUBSTANTIALLY EQUIVALENT	1
PULMONX, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHERIDAN CATHETER CORP.
	SUBSTANTIALLY EQUIVALENT	2
SMITHS
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Leak	18
Air leak	13
Inflation issue	11
Break	7
Dislodged or dislocated	6
Kinked	5
Suction issue	4
Fitting problem	4
Device operates differently than expected	4
Mislabeled	4
Device alarm system issue	3
Balloon leak(s)	2
Bent	2
Deflation issue	2
Foreign material	2
Connection issue	2
Device markings issue	2
No Known Device Problem	2
Hole in material	2
Material separation	2
Pressure issue	2
Unintended movement	1
Device inoperable	1
Other (for use when an appropriate device code cannot be identified)	1
Unknown (for use when the device problem is not known)	1
Device Issue	1
Component or accessory incompatibility	1
Packaging issue	1
Material deformation	1
Difficult to advance	1
Fracture	1
Material fragmentation	1
Difficult to insert	1
Occlusion within device	1
Difficult to position	1
Disconnection	1
Component(s), broken	1
Detachment of device component	1
Total Device Problems	116

Recalls
	2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017
Class I	0	0	0	0	0	0	0	0	1	0	0
Class II	0	0	0	0	0	0	0	0	0	0	1
Class III	0	0	0	0	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Parker Medical	II	Mar-03-2017
2	Teleflex Medical	I	Aug-20-2015