TPLC - Total Product Life Cycle

• Device: syringe, antistick
• Regulation Description: Piston syringe.
• Product Code: MEG
• Regulation Number: 880.5860
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BD
	SUBSTANTIALLY EQUIVALENT	1
BIOTOP TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
EXELINT INTERNATIONAL CO
	SUBSTANTIALLY EQUIVALENT	2
LIFE-SHIELD PRODUCTS, INC
	SUBSTANTIALLY EQUIVALENT	5
MEDICAL DEVICE MANUFACTURER (THAILAND) LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
MEDSAFE ASA
	SUBSTANTIALLY EQUIVALENT	1
NEW MEDICAL TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	2
RETRACTABLE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
SAFETY SYRINGES, INC.
	SUBSTANTIALLY EQUIVALENT	7
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITHS
	SUBSTANTIALLY EQUIVALENT	3
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
ULTIMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Detachment of device component	18
Shielding failure	14
Component(s), broken	5
Needle, unsheathed	4
Break	4
Material puncture	2
Device operational issue	2
Use of Device Issue	2
Unknown (for use when the device problem is not known)	2
Failure to advance	2
Locking mechanism failure	1
Protective measure issue	1
Not Applicable	1
Slippage of device or device component	1
Failure to deploy	1
Failure to capture	1
Bent	1
Blockage within device or device component	1
Total Device Problems	63

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Company	III	Jan-13-2009
2	Inviro Medical Devices, Inc	II	Jun-11-2010