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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
2
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
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
114
114
Leak/Splash
50
50
Device Markings/Labelling Problem
18
18
Complete Blockage
18
18
Defective Component
14
14
Packaging Problem
11
11
Device Contamination with Chemical or Other Material
11
11
Loss of or Failure to Bond
8
8
Product Quality Problem
8
8
Detachment of Device or Device Component
8
8
Material Twisted/Bent
7
7
Nonstandard Device
7
7
Material Integrity Problem
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Material Separation
6
6
No Flow
6
6
Contamination
6
6
Connection Problem
6
6
Fracture
5
5
Defective Device
5
5
Material Deformation
5
5
Disconnection
4
4
Material Fragmentation
4
4
Fluid/Blood Leak
4
4
Device Handling Problem
4
4
Insufficient Flow or Under Infusion
4
4
Physical Resistance/Sticking
3
3
Mechanical Problem
3
3
Patient Device Interaction Problem
3
3
Loose or Intermittent Connection
3
3
Unexpected Color
2
2
Separation Problem
2
2
Off-Label Use
2
2
Sharp Edges
2
2
Air/Gas in Device
2
2
Difficult to Open or Remove Packaging Material
2
2
Patient-Device Incompatibility
2
2
Lack of Effect
2
2
Partial Blockage
2
2
Failure to Deliver
2
2
Infusion or Flow Problem
2
2
Entrapment of Device
2
2
Improper Flow or Infusion
2
2
Tear, Rip or Hole in Device Packaging
1
1
Delivered as Unsterile Product
1
1
Difficult to Remove
1
1
Appropriate Term/Code Not Available
1
1
Inadequacy of Device Shape and/or Size
1
1
Failure to Disconnect
1
1
Material Protrusion/Extrusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
198
198
Foreign Body In Patient
57
57
Insufficient Information
23
23
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
Device Embedded In Tissue or Plaque
6
6
Pain
5
5
Needle Stick/Puncture
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Headache
3
3
No Information
2
2
Cerebrospinal Fluid Leakage
2
2
Hematoma
2
2
Nerve Damage
2
2
Death
2
2
Hemorrhage/Bleeding
2
2
Cognitive Changes
1
1
Chills
1
1
Injury
1
1
Tissue Damage
1
1
Paresthesia
1
1
Blood Loss
1
1
Abscess
1
1
Exposure to Body Fluids
1
1
Spinal Arachnoiditis
1
1
Cardiac Arrest
1
1
Numbness
1
1
Discomfort
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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