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TPLC
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show TPLC since
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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
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
53
53
2022
83
83
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
128
128
Leak/Splash
44
44
Fracture
27
27
Device Markings/Labelling Problem
19
19
Loss of or Failure to Bond
16
16
Detachment of Device or Device Component
16
16
Device Contamination with Chemical or Other Material
13
13
Fluid/Blood Leak
12
12
Packaging Problem
10
10
Defective Component
9
9
Failure To Adhere Or Bond
8
8
Complete Blockage
7
7
Material Separation
7
7
Material Integrity Problem
6
6
Crack
6
6
Nonstandard Device
6
6
Defective Device
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Entrapment of Device
6
6
Material Deformation
5
5
Material Twisted/Bent
5
5
Manufacturing, Packaging or Shipping Problem
4
4
No Flow
4
4
Therapeutic or Diagnostic Output Failure
3
3
Mechanical Problem
3
3
Component Misassembled
3
3
Contamination /Decontamination Problem
3
3
Connection Problem
3
3
Insufficient Flow or Under Infusion
3
3
Device Handling Problem
3
3
Difficult to Remove
3
3
Patient-Device Incompatibility
2
2
Infusion or Flow Problem
2
2
Off-Label Use
2
2
Material Fragmentation
2
2
Physical Resistance/Sticking
2
2
Detachment Of Device Component
2
2
Product Quality Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Disconnection
2
2
Loose or Intermittent Connection
2
2
Improper Flow or Infusion
2
2
Difficult to Open or Remove Packaging Material
2
2
Incorrect Measurement
2
2
Material Split, Cut or Torn
2
2
Separation Problem
1
1
Output Problem
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Device Or Device Fragments Location Unknown
1
1
Device Dislodged or Dislocated
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Failure to Deliver
1
1
Structural Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Delivered as Unsterile Product
1
1
Material Rupture
1
1
Backflow
1
1
Dull, Blunt
1
1
Difficult to Advance
1
1
Misconnection
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure to Advance
1
1
Contamination of Device Ingredient or Reagent
1
1
Inadequacy of Device Shape and/or Size
1
1
Sticking
1
1
Unexpected Therapeutic Results
1
1
Material Discolored
1
1
Partial Blockage
1
1
Air/Gas in Device
1
1
Hole In Material
1
1
Component Incompatible
1
1
Bent
1
1
Physical Resistance
1
1
Material Protrusion/Extrusion
1
1
Device Operates Differently Than Expected
1
1
Device Damaged by Another Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
101
101
No Known Impact Or Consequence To Patient
97
97
Foreign Body In Patient
56
56
No Consequences Or Impact To Patient
43
43
No Patient Involvement
24
24
Device Embedded In Tissue or Plaque
24
24
No Information
13
13
Insufficient Information
8
8
No Code Available
7
7
Pain
6
6
Inadequate Pain Relief
4
4
Patient Problem/Medical Problem
2
2
Death
2
2
Tissue Damage
2
2
Hematoma
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Exposure to Body Fluids
2
2
Injury
2
2
Needle Stick/Puncture
2
2
Blood Loss
2
2
Cardiac Arrest
1
1
Discomfort
1
1
Numbness
1
1
Underdose
1
1
Abscess
1
1
Cerebrospinal Fluid Leakage
1
1
Chills
1
1
Tingling
1
1
Hemorrhage/Bleeding
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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