TPLC - Total Product Life Cycle

show TPLC since

Device	single use only blood lancet without an integral sharps injury prevention feature
Regulation Description	Blood lancets.
Definition	A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Product Code	QRK
Regulation Number	878.4850
Device Class	2

Premarket Reviews
Manufacturer	Decision
ASCENSIA DIABETES CARE U.S., INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSUNGMEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FACET TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
HTL-STREFA S.A
	SUBSTANTIALLY EQUIVALENT	1
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDIPOINT HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
NINGBO CAREMED MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO MEDSUN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEWON MEDICAL CO.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI CARELIFE INTERNATIONAL TRADING CO. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
STAT MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	3
STERILANCE MEDICAL (SUZHOU), INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Twisted/Bent	12	12
Product Quality Problem	7	7
Dull, Blunt	7	7
Insufficient Information	3	3
Retraction Problem	3	3
Material Separation	3	3
Component Missing	2	2
Detachment of Device or Device Component	1	1
Material Fragmentation	1	1
Defective Component	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	27	27
Bruise/Contusion	3	3
Unspecified Infection	3	3
Hemorrhage/Bleeding	2	2
Pain	2	2
Foreign Body In Patient	1	1
Ecchymosis	1	1
Needle Stick/Puncture	1	1