TPLC - Total Product Life Cycle

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Device	container, sharps
Regulation Description	Hypodermic single lumen needle.
Product Code	MMK
Regulation Number	880.5570
Device Class	2

Premarket Reviews
Manufacturer	Decision
INTERNATIONAL MARKETING SPECIALISTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
KETER CANADA, INC.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO MAXCON MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
NITTA M&T (THAILAND) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PUREWAY COMPLIANCE, INC.
	SUBSTANTIALLY EQUIVALENT	2
QLICKSMART PTY , LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAIZHOU HUANGYAN GUANHONG PLASTIC STEEL PRODUCTS FACTORY
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	37	37
Component Missing	31	31
Difficult to Open or Close	17	17
Defective Component	12	12
Device Misassembled During Manufacturing /Shipping	12	12
Device Damaged Prior to Use	10	10
Material Puncture/Hole	8	8
Mechanical Problem	7	7
Device Markings/Labelling Problem	5	5
Component or Accessory Incompatibility	4	4
Fail-Safe Problem	4	4
Material Protrusion/Extrusion	4	4
Crack	3	3
Failure to Cut	3	3
Incomplete or Inadequate Connection	2	2
Material Perforation	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Mechanical Jam	2	2
Leak/Splash	1	1
Separation Problem	1	1
Unsealed Device Packaging	1	1
Defective Device	1	1
Use of Device Problem	1	1
Misassembly by Users	1	1
Nonstandard Device	1	1
Component Incompatible	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	146	146
Needle Stick/Puncture	18	18
Insufficient Information	13	13
No Consequences Or Impact To Patient	8	8
Exposure to Body Fluids	3	3
No Patient Involvement	2	2
Pain	1	1
Urinary Tract Infection	1	1