TPLC - Total Product Life Cycle

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Device	needle, conduction, anesthetic (w/wo introducer)
Product Code	BSP
Regulation Number	868.5150
Device Class	2

Premarket Reviews
Manufacturer	Decision
AERIN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
ANCORA MEDICAL TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	3
DISCCATH LLC
	SUBSTANTIALLY EQUIVALENT	1
DR. JAPAN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL MEDIKIT LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MYCO MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PAJUNK GMBH MEDIZINTECHNOLOGIE
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	135	135
Leak/Splash	57	57
Device Markings/Labelling Problem	22	22
Detachment of Device or Device Component	17	17
Loss of or Failure to Bond	16	16
Device Contamination with Chemical or Other Material	14	14
Defective Component	14	14
Fracture	12	12
Packaging Problem	12	12
Material Separation	9	9
Complete Blockage	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Material Integrity Problem	7	7
No Flow	6	6
Nonstandard Device	6	6
Defective Device	6	6
Material Twisted/Bent	6	6
Fluid/Blood Leak	5	5
Connection Problem	5	5
Material Deformation	5	5
Component Misassembled	4	4
Device Handling Problem	4	4
Insufficient Flow or Under Infusion	4	4
Material Fragmentation	4	4
Disconnection	4	4
Crack	4	4
Loose or Intermittent Connection	3	3
Entrapment of Device	3	3
Contamination /Decontamination Problem	3	3
Patient Device Interaction Problem	3	3
Mechanical Problem	3	3
Physical Resistance/Sticking	3	3
Therapeutic or Diagnostic Output Failure	3	3
Appropriate Term/Code Not Available	2	2
Off-Label Use	2	2
Difficult to Open or Remove Packaging Material	2	2
Output Problem	2	2
Partial Blockage	2	2
Unexpected Color	2	2
Patient-Device Incompatibility	2	2
Lack of Effect	2	2
Infusion or Flow Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Improper Flow or Infusion	2	2
Contamination	2	2
Air/Gas in Device	2	2
Failure to Deliver	2	2
Difficult to Remove	2	2
Insufficient Information	1	1
Misconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	173	173
No Known Impact Or Consequence To Patient	59	59
Foreign Body In Patient	57	57
No Consequences Or Impact To Patient	30	30
No Patient Involvement	20	20
Insufficient Information	19	19
Device Embedded In Tissue or Plaque	16	16
No Information	7	7
Pain	6	6
Needle Stick/Puncture	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Code Available	3	3
Headache	3	3
Inadequate Pain Relief	3	3
Patient Problem/Medical Problem	2	2
Death	2	2
Hematoma	2	2
Blood Loss	2	2
Injury	2	2
Exposure to Body Fluids	2	2
Discomfort	2	2
Cerebrospinal Fluid Leakage	2	2
Tissue Damage	2	2
Hemorrhage/Bleeding	2	2
Tingling	1	1
Cognitive Changes	1	1
Cardiac Arrest	1	1
Paresthesia	1	1
Chills	1	1
Numbness	1	1
Spinal Arachnoiditis	1	1
Abscess	1	1