TPLC - Total Product Life Cycle

Device	lancet, blood
Regulation Description	Manual surgical instrument for general use.
Product Code	FMK
Regulation Number	878.4800
Device Class	1

Premarket Reviews
Manufacturer	Decision
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	1
GAINOR MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
HOME DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL TECHNIDYNE CORP.
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SUBSTANTIALLY EQUIVALENT	2
KULZER
	SUBSTANTIALLY EQUIVALENT	1
PALCO LABS, INC
	SUBSTANTIALLY EQUIVALENT	1
PELIKAN TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
PRIMROSE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Retraction problem	5444
Spring loading mechanism problem	169
Needle, unsheathed	113
Incorrect or inadequate result	74
Delivered as unsterile product	66
Material fragmentation	29
Replace	27
Device, or device fragments remain in patient	22
Other (for use when an appropriate device code cannot be identified)	19
No Known Device Problem	16
Incorrect or inadequate test results	14
Detachment of device or device component	13
Material Protrusion	11
Failure to obtain samples	10
Unknown (for use when the device problem is not known)	8
Unable to obtain readings	6
Device contamination with blood or blood product	6
Needle, separation	5
Improper or incorrect procedure or method	3
Failure to fire	3
Failure to prime	3
Reuse	3
Break	3
Inaccurate delivery	3
Use of Device Issue	3
Not Applicable	2
Device or device fragments location unknown	2
Expiration date error	2
Material separation	1
Sterility	1
Pierce	1
Incomplete or missing packaging	1
Device packaging compromised	1
Device remains implanted	1
Out-of-box failure	1
Unsealed device packaging	1
Detachment of device component	1
Product quality issue	1
Size incorrect for patient	1
Failure of device to self-test	1
Contamination during use	1
Mechanical issue	1
Incorrect display	1
Failure to cut	1
Shielding failure	1
Failure to unfold or unwrap	1
Burn of device or device component	1
Malfunction	1
Needle, dull	1
Total Device Problems	6100