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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
DISCCATH LLC
SUBSTANTIALLY EQUIVALENT
1
DR. JAPAN CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
GLOBAL MEDIKIT LIMITED
SUBSTANTIALLY EQUIVALENT
1
MYCO MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SUBSTANTIALLY EQUIVALENT
1
1. K192914
Stimuplex Onvision System
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
86
86
2020
77
77
2021
52
52
2022
83
83
2023
75
75
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
128
128
Leak/Splash
54
54
Device Markings/Labelling Problem
21
21
Detachment of Device or Device Component
17
17
Loss of or Failure to Bond
16
16
Device Contamination with Chemical or Other Material
14
14
Defective Component
13
13
Fracture
12
12
Packaging Problem
12
12
Complete Blockage
9
9
Adverse Event Without Identified Device or Use Problem
8
8
Material Integrity Problem
7
7
Material Separation
7
7
Defective Device
6
6
Fluid/Blood Leak
5
5
Material Deformation
5
5
Connection Problem
5
5
Material Twisted/Bent
5
5
No Flow
4
4
Device Handling Problem
4
4
Component Misassembled
4
4
Insufficient Flow or Under Infusion
4
4
Nonstandard Device
4
4
Disconnection
4
4
Material Fragmentation
3
3
Mechanical Problem
3
3
Crack
3
3
Contamination /Decontamination Problem
3
3
Patient Device Interaction Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Output Problem
2
2
Physical Resistance/Sticking
2
2
Unexpected Color
2
2
Air/Gas in Device
2
2
Lack of Effect
2
2
Appropriate Term/Code Not Available
2
2
Difficult to Open or Remove Packaging Material
2
2
Improper Flow or Infusion
2
2
Infusion or Flow Problem
2
2
Contamination
2
2
Partial Blockage
2
2
Loose or Intermittent Connection
2
2
Entrapment of Device
2
2
Off-Label Use
2
2
Difficult to Remove
2
2
Patient-Device Incompatibility
2
2
Failure to Deliver
2
2
Tear, Rip or Hole in Device Packaging
1
1
Dull, Blunt
1
1
Obstruction of Flow
1
1
Structural Problem
1
1
Microbial Contamination of Device
1
1
Incomplete or Missing Packaging
1
1
Inadequacy of Device Shape and/or Size
1
1
Unexpected Therapeutic Results
1
1
Product Quality Problem
1
1
Device Appears to Trigger Rejection
1
1
Delivered as Unsterile Product
1
1
Labelling, Instructions for Use or Training Problem
1
1
Misconnection
1
1
Backflow
1
1
Component Incompatible
1
1
Material Discolored
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Protrusion/Extrusion
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Device Damaged by Another Device
1
1
Difficult to Advance
1
1
Separation Problem
1
1
Material Split, Cut or Torn
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
159
159
No Known Impact Or Consequence To Patient
59
59
Foreign Body In Patient
53
53
No Consequences Or Impact To Patient
30
30
No Patient Involvement
20
20
Insufficient Information
15
15
Device Embedded In Tissue or Plaque
15
15
No Information
7
7
Pain
4
4
Headache
3
3
Inadequate Pain Relief
3
3
Needle Stick/Puncture
3
3
No Code Available
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Patient Problem/Medical Problem
2
2
Blood Loss
2
2
Hematoma
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
Cardiac Arrest
1
1
Tingling
1
1
Chills
1
1
Hemorrhage/Bleeding
1
1
Abscess
1
1
Cognitive Changes
1
1
Paresthesia
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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