TPLC - Total Product Life Cycle

• 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
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	86	86
2020	77	77
2021	52	52
2022	83	83
2023	75	75
2024	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	128	128
Leak/Splash	54	54
Device Markings/Labelling Problem	21	21
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	13	13
Fracture	12	12
Packaging Problem	12	12
Complete Blockage	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Material Integrity Problem	7	7
Material Separation	7	7
Defective Device	6	6
Fluid/Blood Leak	5	5
Material Deformation	5	5
Connection Problem	5	5
Material Twisted/Bent	5	5
No Flow	4	4
Device Handling Problem	4	4
Component Misassembled	4	4
Insufficient Flow or Under Infusion	4	4
Nonstandard Device	4	4
Disconnection	4	4
Material Fragmentation	3	3
Mechanical Problem	3	3
Crack	3	3
Contamination /Decontamination Problem	3	3
Patient Device Interaction Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Output Problem	2	2
Physical Resistance/Sticking	2	2
Unexpected Color	2	2
Air/Gas in Device	2	2
Lack of Effect	2	2
Appropriate Term/Code Not Available	2	2
Difficult to Open or Remove Packaging Material	2	2
Improper Flow or Infusion	2	2
Infusion or Flow Problem	2	2
Contamination	2	2
Partial Blockage	2	2
Loose or Intermittent Connection	2	2
Entrapment of Device	2	2
Off-Label Use	2	2
Difficult to Remove	2	2
Patient-Device Incompatibility	2	2
Failure to Deliver	2	2
Tear, Rip or Hole in Device Packaging	1	1
Dull, Blunt	1	1
Obstruction of Flow	1	1
Structural Problem	1	1
Microbial Contamination of Device	1	1
Incomplete or Missing Packaging	1	1
Inadequacy of Device Shape and/or Size	1	1
Unexpected Therapeutic Results	1	1
Product Quality Problem	1	1
Device Appears to Trigger Rejection	1	1
Delivered as Unsterile Product	1	1
Labelling, Instructions for Use or Training Problem	1	1
Misconnection	1	1
Backflow	1	1
Component Incompatible	1	1
Material Discolored	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Protrusion/Extrusion	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Device Damaged by Another Device	1	1
Difficult to Advance	1	1
Separation Problem	1	1
Material Split, Cut or Torn	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	159	159
No Known Impact Or Consequence To Patient	59	59
Foreign Body In Patient	53	53
No Consequences Or Impact To Patient	30	30
No Patient Involvement	20	20
Insufficient Information	15	15
Device Embedded In Tissue or Plaque	15	15
No Information	7	7
Pain	4	4
Headache	3	3
Inadequate Pain Relief	3	3
Needle Stick/Puncture	3	3
No Code Available	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Patient Problem/Medical Problem	2	2
Blood Loss	2	2
Hematoma	2	2
Discomfort	2	2
Injury	2	2
Tissue Damage	2	2
Exposure to Body Fluids	2	2
Cerebrospinal Fluid Leakage	2	2
Death	2	2
Cardiac Arrest	1	1
Tingling	1	1
Chills	1	1
Hemorrhage/Bleeding	1	1
Abscess	1	1
Cognitive Changes	1	1
Paresthesia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arrow International Inc	II	Feb-14-2020
2	Pajunk GmbH	II	Oct-29-2019
3	Smiths Medical ASD Inc.	II	Oct-19-2021
4	TELEFLEX MEDICAL INC	II	May-26-2020