TPLC - Total Product Life Cycle

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Device	needle, conduction, anesthetic (w/wo introducer)
Regulation Description	Anesthesia conduction needle.
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
GLOBAL MEDIKIT LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MYCO MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PAJUNK GMBH MEDIZINTECHNOLOGIE
	SUBSTANTIALLY EQUIVALENT	3
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	119	119
Leak/Splash	50	50
Complete Blockage	23	23
Device Markings/Labelling Problem	18	18
Defective Component	14	14
Device Contamination with Chemical or Other Material	11	11
Packaging Problem	11	11
Product Quality Problem	9	9
Loss of or Failure to Bond	8	8
Nonstandard Device	8	8
Detachment of Device or Device Component	8	8
Material Twisted/Bent	7	7
No Flow	6	6
Connection Problem	6	6
Material Separation	6	6
Material Integrity Problem	6	6
Contamination	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Disconnection	5	5
Fracture	5	5
Defective Device	5	5
Material Deformation	5	5
Fluid/Blood Leak	4	4
Device Handling Problem	4	4
Material Fragmentation	4	4
Insufficient Flow or Under Infusion	4	4
Loose or Intermittent Connection	3	3
Mechanical Problem	3	3
Physical Resistance/Sticking	3	3
Patient Device Interaction Problem	3	3
Partial Blockage	2	2
Unexpected Color	2	2
Difficult or Delayed Separation	2	2
Lack of Effect	2	2
Sharp Edges	2	2
Infusion or Flow Problem	2	2
Improper Flow or Infusion	2	2
Obstruction of Flow	2	2
Air/Gas in Device	2	2
Failure to Deliver	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Patient-Device Incompatibility	2	2
Crack	2	2
Difficult to Open or Remove Packaging Material	2	2
Off-Label Use	2	2
Entrapment of Device	2	2
Separation Problem	2	2
Material Discolored	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	210	210
Foreign Body In Patient	61	61
Insufficient Information	24	24
No Known Impact Or Consequence To Patient	21	21
No Patient Involvement	15	15
No Consequences Or Impact To Patient	14	14
Inadequate Pain Relief	8	8
Device Embedded In Tissue or Plaque	6	6
Pain	5	5
Needle Stick/Puncture	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Headache	3	3
Death	2	2
No Information	2	2
Hematoma	2	2
Nerve Damage	2	2
Cerebrospinal Fluid Leakage	2	2
Hemorrhage/Bleeding	2	2
Blood Loss	1	1
Cognitive Changes	1	1
Cardiac Arrest	1	1
Paresthesia	1	1
Injury	1	1
Chills	1	1
Exposure to Body Fluids	1	1
Discomfort	1	1
Numbness	1	1
Spinal Arachnoiditis	1	1
Abscess	1	1
Tissue Damage	1	1
Nervous System Injury	1	1