TPLC - Total Product Life Cycle

show TPLC since

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
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	2
DISCCATH, LLC
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL MEDIKIT LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MYCO MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PAJUNK GMBH MEDIZINTECHNOLOGIE
	SUBSTANTIALLY EQUIVALENT	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	120	121
Leak/Splash	51	51
Complete Blockage	23	23
Defective Component	16	16
Device Markings/Labelling Problem	14	14
Packaging Problem	11	11
Contamination	11	11
Product Quality Problem	10	10
Detachment of Device or Device Component	9	9
Lack of Effect	8	8
Nonstandard Device	8	8
Connection Problem	8	8
Material Integrity Problem	8	8
Defective Device	7	7
Material Separation	6	6
Device Contamination with Chemical or Other Material	6	6
Fracture	6	6
Material Twisted/Bent	5	5
Obstruction of Flow	5	5
Difficult to Open or Remove Packaging Material	5	5
Disconnection	5	5
Loose or Intermittent Connection	4	4
Loss of or Failure to Bond	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Device Handling Problem	4	4
No Flow	3	3
Crack	3	3
Patient Device Interaction Problem	3	3
Material Fragmentation	3	3
Fluid/Blood Leak	3	3
Insufficient Flow or Under Infusion	3	3
Off-Label Use	3	3
Mechanical Problem	3	3
Entrapment of Device	3	3
Insufficient Information	2	2
Patient-Device Incompatibility	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Inaccurate Information	2	2
Incomplete or Inadequate Connection	2	2
Air/Gas in Device	2	2
Physical Resistance/Sticking	2	2
Infusion or Flow Problem	2	2
Sharp Edges	2	2
Material Deformation	2	2
Difficult or Delayed Separation	2	2
Unexpected Color	2	2
Partial Blockage	2	2
Separation Problem	2	2
Temperature Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	245	246
Foreign Body In Patient	78	78
Insufficient Information	36	36
Pain	10	10
Inadequate Pain Relief	8	8
Hematoma	5	5
Device Embedded In Tissue or Plaque	5	5
Headache	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Needle Stick/Puncture	3	3
Nerve Damage	2	2
Discomfort	2	2
No Consequences Or Impact To Patient	2	2
Intra-Abdominal Hemorrhage	1	1
Cognitive Changes	1	1
Paresthesia	1	1
Numbness	1	1
Spinal Arachnoiditis	1	1
Abscess	1	1
Bradycardia	1	1
Cerebrospinal Fluid Leakage	1	1
Hemorrhage/Bleeding	1	1
Low Blood Pressure/ Hypotension	1	1
Nervous System Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smiths Medical ASD Inc.	II	Oct-19-2021