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	6
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	146	146
Leak/Splash	55	55
Complete Blockage	23	23
Device Markings/Labelling Problem	18	18
Defective Component	16	16
Packaging Problem	12	12
Device Contamination with Chemical or Other Material	11	14
Product Quality Problem	9	9
Contamination	9	9
Loss of or Failure to Bond	8	8
Nonstandard Device	8	8
Detachment of Device or Device Component	8	8
Connection Problem	7	7
Material Separation	7	7
Material Integrity Problem	7	7
Material Twisted/Bent	7	7
No Flow	6	6
Fracture	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Disconnection	5	5
Off-Label Use	5	5
Material Deformation	5	5
Defective Device	5	5
Fluid/Blood Leak	4	4
Device Handling Problem	4	4
Lack of Effect	4	4
Insufficient Flow or Under Infusion	4	4
Obstruction of Flow	4	4
Material Fragmentation	4	4
Loose or Intermittent Connection	3	3
Patient Device Interaction Problem	3	3
Mechanical Problem	3	3
Patient-Device Incompatibility	3	3
Crack	3	3
Physical Resistance/Sticking	3	3
Failure to Deliver	2	2
Air/Gas in Device	2	2
Separation Problem	2	2
Entrapment of Device	2	2
Improper Flow or Infusion	2	2
Infusion or Flow Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Sharp Edges	2	2
Insufficient Information	2	2
Difficult to Open or Remove Packaging Material	2	2
Difficult or Delayed Separation	2	2
Unexpected Color	2	2
Partial Blockage	2	2
Fitting Problem	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	230	230
Foreign Body In Patient	83	83
Insufficient Information	26	26
No Known Impact Or Consequence To Patient	21	24
No Patient Involvement	15	15
No Consequences Or Impact To Patient	14	14
Pain	8	8
Inadequate Pain Relief	8	8
Device Embedded In Tissue or Plaque	7	7
Needle Stick/Puncture	4	4
Headache	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Death	2	2
No Information	2	2
Hematoma	2	2
Nerve Damage	2	2
Discomfort	2	2
Cerebrospinal Fluid Leakage	2	2
Hemorrhage/Bleeding	2	2
Intra-Abdominal Hemorrhage	1	1
Cognitive Changes	1	1
Blood Loss	1	1
Cardiac Arrest	1	1
Paresthesia	1	1
Chills	1	1
Injury	1	1
Exposure to Body Fluids	1	1
Muscle Spasm(s)	1	1
Numbness	1	1
Spinal Arachnoiditis	1	1
Abscess	1	1
Bradycardia	1	1
Tissue Damage	1	1
Low Blood Pressure/ Hypotension	1	1
Nervous System Injury	1	1