TPLC - Total Product Life Cycle

• Device: bottle, collection, vacuum
• Regulation Description: Vacuum-powered body fluid suction apparatus.
• Product Code: KDQ
• Regulation Number: 880.6740
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ATRIUM MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	8
BENTLEY LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	3
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
1.  K812746  THORACIC DRAINAGE SET #55-DB2-G
KENDALL
	SUBSTANTIALLY EQUIVALENT	2
PRECISION MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SAGE PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
SNYDER LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Vacuum, loss of	94
Break	13
Other (for use when an appropriate device code cannot be identified)	11
Material separation	9
Leak	6
Air leak	6
Component(s), broken	4
Disconnection	3
Device, or device fragments remain in patient	3
Difficult to remove	2
Material disintegration	2
Fluid leak	2
Suction issue	2
Device Issue	2
Malfunction	2
Use of Device Issue	2
Locking mechanism failure	1
Detachment of device or device component	1
Tube(s), defective	1
Bacterial contamination of device	1
Absorption	1
Detachment of device component	1
Couple, failure to	1
Crack	1
Design/structure problem	1
Replace	1
Retraction problem	1
Method, improper/incorrect	1
Migration of device or device component	1
Syringe, defective	1
Tubing, incorrect placement of	1
Total Device Problems	178

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	1	1	0	0	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	DeRoyal Industries Inc	II	Oct-20-2010
2	Ohio Medical Corporation	II	Oct-29-2009