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	11	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	129	129
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
Material Separation	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Material Integrity Problem	7	7
Material Twisted/Bent	6	6
Defective Device	6	6
Fluid/Blood Leak	5	5
Material Deformation	5	5
Connection Problem	5	5
Insufficient Flow or Under Infusion	4	4
No Flow	4	4
Device Handling Problem	4	4
Component Misassembled	4	4
Nonstandard Device	4	4
Disconnection	4	4
Entrapment of Device	3	3
Material Fragmentation	3	3
Mechanical Problem	3	3
Crack	3	3
Patient Device Interaction Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Contamination /Decontamination Problem	3	3
Difficult to Open or Remove Packaging Material	2	2
Improper Flow or Infusion	2	2
Infusion or Flow Problem	2	2
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
Contamination	2	2
Partial Blockage	2	2
Loose or Intermittent Connection	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
Failure to Disconnect	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
Misconnection	1	1
Labelling, Instructions for Use or Training Problem	1	1
Backflow	1	1
Component Incompatible	1	1
Material Discolored	1	1
Separation Problem	1	1
Material Split, Cut or Torn	1	1
Insufficient Information	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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	160	160
No Known Impact Or Consequence To Patient	59	59
Foreign Body In Patient	54	54
No Consequences Or Impact To Patient	30	30
No Patient Involvement	20	20
Device Embedded In Tissue or Plaque	15	15
Insufficient Information	15	15
No Information	7	7
Needle Stick/Puncture	4	4
Pain	4	4
Inadequate Pain Relief	3	3
Headache	3	3
No Code Available	3	3
Blood Loss	2	2
Patient Problem/Medical Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hematoma	2	2
Hemorrhage/Bleeding	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
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