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TPLC
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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
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
DISCCATH LLC
SUBSTANTIALLY EQUIVALENT
1
DR. JAPAN CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
GLOBAL MEDIKIT LIMITED
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD)
SUBSTANTIALLY EQUIVALENT
1
MYCO MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
3
SUMMIT MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
2
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
69
69
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
144
144
Leak/Splash
59
59
Fracture
28
28
Device Markings/Labelling Problem
23
23
Detachment of Device or Device Component
19
19
Loss of or Failure to Bond
17
17
Fluid/Blood Leak
14
14
Device Contamination with Chemical or Other Material
14
14
Defective Component
13
13
Packaging Problem
12
12
Adverse Event Without Identified Device or Use Problem
9
9
Material Integrity Problem
9
9
Material Separation
9
9
Complete Blockage
9
9
Failure To Adhere Or Bond
8
8
Entrapment of Device
7
7
Material Twisted/Bent
7
7
Device Handling Problem
7
7
Material Deformation
6
6
Nonstandard Device
6
6
Connection Problem
6
6
Defective Device
6
6
Crack
5
5
Disconnection
5
5
Material Fragmentation
4
4
Insufficient Flow or Under Infusion
4
4
Patient-Device Incompatibility
4
4
Manufacturing, Packaging or Shipping Problem
4
4
No Flow
4
4
Component Misassembled
4
4
Patient Device Interaction Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Contamination /Decontamination Problem
3
3
Mechanical Problem
3
3
Difficult to Remove
3
3
Off-Label Use
2
2
Product Quality Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Loose or Intermittent Connection
2
2
Incorrect Measurement
2
2
Contamination
2
2
Partial Blockage
2
2
Detachment Of Device Component
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Improper Flow or Infusion
2
2
Infusion or Flow Problem
2
2
Difficult to Open or Remove Packaging Material
2
2
Improper or Incorrect Procedure or Method
2
2
Structural Problem
2
2
Failure to Deliver
2
2
Appropriate Term/Code Not Available
2
2
Output Problem
2
2
Unexpected Color
2
2
Air/Gas in Device
2
2
Lack of Effect
2
2
Material Split, Cut or Torn
2
2
Physical Resistance/Sticking
2
2
Separation Problem
1
1
Insufficient Information
1
1
Tear, Rip or Hole in Device Packaging
1
1
Dull, Blunt
1
1
Obstruction of Flow
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Incomplete or Missing Packaging
1
1
Failure to Advance
1
1
Failure to Disconnect
1
1
Physical Resistance
1
1
Device Or Device Fragments Location Unknown
1
1
Device Dislodged or Dislocated
1
1
Material Protrusion/Extrusion
1
1
Device Operates Differently Than Expected
1
1
Device Damaged by Another Device
1
1
Difficult to Advance
1
1
Contamination of Device Ingredient or Reagent
1
1
Component Incompatible
1
1
Bent
1
1
Backflow
1
1
Material Discolored
1
1
Hole In Material
1
1
Labelling, Instructions for Use or Training Problem
1
1
Misconnection
1
1
Delivered as Unsterile Product
1
1
Sticking
1
1
Unexpected Therapeutic Results
1
1
Device Appears to Trigger Rejection
1
1
Material Rupture
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
97
97
Foreign Body In Patient
66
66
No Consequences Or Impact To Patient
43
43
Device Embedded In Tissue or Plaque
25
25
No Patient Involvement
24
24
Insufficient Information
15
15
No Information
13
13
No Code Available
7
7
Pain
7
7
Inadequate Pain Relief
4
4
Needle Stick/Puncture
4
4
Headache
3
3
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
Patient Problem/Medical Problem
2
2
Blood Loss
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Abscess
1
1
Paresthesia
1
1
Cardiac Arrest
1
1
Tingling
1
1
Chills
1
1
Underdose
1
1
Cognitive Changes
1
1
Numbness
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
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