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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
B. BRAUN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
B.BRAUN MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
BECTON DICKSON & CO.
SUBSTANTIALLY EQUIVALENT
1
BECTON, DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
3
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
COOK, INC.
SUBSTANTIALLY EQUIVALENT
2
1. K093209
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
2. K101728
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
DISCCATH LLC
SUBSTANTIALLY EQUIVALENT
1
DR. JAPAN CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ENTELLUS MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
GLOBAL MEDIKIT LIMITED
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD)
SUBSTANTIALLY EQUIVALENT
1
LAURIMED LLC
SUBSTANTIALLY EQUIVALENT
2
LCCS PRODUCTS LIMITED
SUBSTANTIALLY EQUIVALENT
1
LIFE-TECH, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE, INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MYCO MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PAJUNK GMBH
SUBSTANTIALLY EQUIVALENT
1
PAJUNK GMBH MEDIZINTECHNOLOGIE
SUBSTANTIALLY EQUIVALENT
6
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SUBSTANTIALLY EQUIVALENT
1
REMINGTON MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
4
SOLO-DEX, INC.
SUBSTANTIALLY EQUIVALENT
1
SPECTRA MEDICAL DEVICES
SUBSTANTIALLY EQUIVALENT
1
SPECTRA MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
SUMMIT MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
2
ULTRASONIX MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
UNISIS CORP.
SUBSTANTIALLY EQUIVALENT
2
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
40
40
2015
38
38
2016
152
152
2017
34
34
2018
69
69
2019
86
86
2020
77
77
2021
52
52
2022
83
83
2023
75
75
2024
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
218
218
Leak/Splash
77
77
Fracture
48
48
Fluid/Blood Leak
43
43
Nonstandard Device
41
41
No Flow
40
40
Product Quality Problem
39
39
Manufacturing, Packaging or Shipping Problem
37
37
Device Markings/Labelling Problem
28
28
Partial Blockage
28
28
Crack
26
26
Device Operates Differently Than Expected
25
25
Device Handling Problem
24
24
Detachment of Device or Device Component
20
20
Detachment Of Device Component
18
18
Loss of or Failure to Bond
17
17
Packaging Problem
16
16
Device Contamination with Chemical or Other Material
15
15
Adverse Event Without Identified Device or Use Problem
14
14
Bent
14
14
Defective Component
14
14
Patient-Device Incompatibility
13
13
Insufficient Information
13
13
Difficult to Remove
12
12
Material Fragmentation
11
11
Mechanical Jam
10
10
Material Separation
10
10
Inadequacy of Device Shape and/or Size
10
10
Failure To Adhere Or Bond
10
10
Material Integrity Problem
10
10
Improper or Incorrect Procedure or Method
9
9
Complete Blockage
9
9
Device Issue
9
9
Device Misassembled During Manufacturing /Shipping
8
8
Fitting Problem
8
8
Incorrect Device Or Component Shipped
8
8
Defective Device
8
8
Connection Problem
8
8
Material Twisted/Bent
7
7
Entrapment of Device
7
7
Material Deformation
7
7
Disconnection
5
5
Insufficient Flow or Under Infusion
5
5
Loose or Intermittent Connection
5
5
Physical Resistance
4
4
Occlusion Within Device
4
4
Component Misassembled
4
4
Contamination /Decontamination Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Component Missing
3
3
Appropriate Term/Code Not Available
3
3
Infusion or Flow Problem
3
3
Contamination
3
3
Difficult to Insert
3
3
Mechanical Problem
3
3
Improper Flow or Infusion
3
3
Output Problem
3
3
Flushing Problem
3
3
Sticking
3
3
Device Packaging Compromised
3
3
Patient Device Interaction Problem
3
3
Human Factors Issue
3
3
Off-Label Use
2
2
Physical Resistance/Sticking
2
2
Device-Device Incompatibility
2
2
Air/Gas in Device
2
2
Unexpected Color
2
2
Difficult to Open or Remove Packaging Material
2
2
Dull, Blunt
2
2
Component Falling
2
2
Material Rupture
2
2
Device Disinfection Or Sterilization Issue
2
2
Failure to Advance
2
2
Failure to Prime
2
2
Physical Property Issue
2
2
Failure to Deliver
2
2
Structural Problem
2
2
Device Dislodged or Dislocated
2
2
Incorrect Measurement
2
2
Material Split, Cut or Torn
2
2
Lack of Effect
2
2
Delivered as Unsterile Product
1
1
Backflow
1
1
No Apparent Adverse Event
1
1
Obstruction of Flow
1
1
Material Puncture/Hole
1
1
Retraction Problem
1
1
Migration or Expulsion of Device
1
1
Inflation Problem
1
1
Unexpected Therapeutic Results
1
1
Material Discolored
1
1
Tear, Rip or Hole in Device Packaging
1
1
Device Contamination with Body Fluid
1
1
Misconnection
1
1
Device Appears to Trigger Rejection
1
1
Compatibility Problem
1
1
Corroded
1
1
Failure to Disconnect
1
1
Difficult to Advance
1
1
Malposition of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
198
198
No Clinical Signs, Symptoms or Conditions
165
165
No Consequences Or Impact To Patient
101
101
Foreign Body In Patient
77
77
Device Embedded In Tissue or Plaque
54
54
No Patient Involvement
54
54
No Information
47
47
Awareness during Anaesthesia
33
33
Inadequate Pain Relief
24
24
Pain
21
21
No Code Available
17
17
Insufficient Information
16
16
Bradycardia
10
10
Cardiac Arrest
10
10
Low Blood Pressure/ Hypotension
7
7
Headache
5
5
Cerebrospinal Fluid Leakage
5
5
Needle Stick/Puncture
5
5
Tissue Damage
4
4
Hemorrhage/Bleeding
4
4
Injury
3
3
Numbness
3
3
Discomfort
2
2
Death
2
2
Hematoma
2
2
Cardiopulmonary Arrest
2
2
Exposure to Body Fluids
2
2
Abscess
2
2
Blood Loss
2
2
Patient Problem/Medical Problem
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Spinal Arachnoiditis
1
1
Paresthesia
1
1
Not Applicable
1
1
Underdose
1
1
Cognitive Changes
1
1
Vessel Or Plaque, Device Embedded In
1
1
Cellulitis
1
1
Incompetent Cervix
1
1
Edema
1
1
Fall
1
1
Complaint, Ill-Defined
1
1
Toxicity
1
1
Anxiety
1
1
Fungal Infection
1
1
Weakness
1
1
Tingling
1
1
Chills
1
1
Respiratory Distress
1
1
Scar Tissue
1
1
Therapeutic Effects, Unexpected
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Feb-14-2020
2
B. Braun Medical, Inc.
II
May-28-2014
3
Epimed International, Inc.
II
Oct-31-2016
4
Integra LifeSciences Corp. d.b.a. Integra Pain Management
II
Jul-09-2015
5
Integra LifeSciences Corp. d.b.a. Integra Pain Management
II
Apr-29-2015
6
Pajunk GmbH
II
Oct-29-2019
7
RM Temena GmbH
II
May-12-2014
8
Smiths Medical ASD Inc.
II
Oct-19-2021
9
TELEFLEX MEDICAL INC
II
May-26-2020
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