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TPLC
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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
MDR Year
MDR Reports
MDR Events
2020
77
77
2021
52
52
2022
84
84
2023
75
75
2024
66
66
2025
40
40
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
124
124
Leak/Splash
51
51
Complete Blockage
23
23
Device Markings/Labelling Problem
18
18
Defective Component
16
16
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
Contamination
8
8
Material Separation
7
7
Material Twisted/Bent
7
7
No Flow
6
6
Connection Problem
6
6
Material Integrity Problem
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
Lack of Effect
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
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
215
215
Foreign Body In Patient
66
66
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
Pain
7
7
Device Embedded In Tissue or Plaque
6
6
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
Discomfort
2
2
Cerebrospinal Fluid Leakage
2
2
Hemorrhage/Bleeding
2
2
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
Numbness
1
1
Spinal Arachnoiditis
1
1
Abscess
1
1
Tissue Damage
1
1
Nervous System Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Feb-14-2020
2
Smiths Medical ASD Inc.
II
Oct-19-2021
3
TELEFLEX MEDICAL INC
II
May-26-2020
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