Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
introducer, syringe needle
Product Code
KZH
Regulation Number
880.6920
Device Class
2
Premarket Reviews
Manufacturer
Decision
EMED TECHNOLOGIES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
95
95
2020
157
157
2021
87
87
2022
58
58
2023
35
35
2024
20
20
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Ejection
157
157
Misfire
84
84
Break
27
27
Defective Device
24
24
Physical Resistance/Sticking
17
17
Mechanical Jam
13
13
Failure to Deliver
13
13
Therapeutic or Diagnostic Output Failure
12
12
Defective Component
11
11
Material Twisted/Bent
9
9
Fluid/Blood Leak
9
9
Output Problem
8
8
Mechanical Problem
5
5
Activation, Positioning or Separation Problem
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Leak/Splash
5
5
Insufficient Information
4
4
Dull, Blunt
3
3
Device Slipped
3
3
Use of Device Problem
3
3
Ejection Problem
3
3
Inaccurate Delivery
3
3
Failure to Infuse
3
3
Failure to Eject
2
2
Patient-Device Incompatibility
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Improper Flow or Infusion
2
2
Difficult to Remove
2
2
Insufficient Flow or Under Infusion
2
2
Key or Button Unresponsive/not Working
2
2
Detachment of Device or Device Component
2
2
Failure to Fire
2
2
Packaging Problem
2
2
Firing Problem
1
1
Shipping Damage or Problem
1
1
Difficult to Insert
1
1
Loss of or Failure to Bond
1
1
Noise, Audible
1
1
Unexpected Therapeutic Results
1
1
Connection Problem
1
1
Naturally Worn
1
1
Use of Incorrect Control/Treatment Settings
1
1
No Flow
1
1
Improper or Incorrect Procedure or Method
1
1
No Apparent Adverse Event
1
1
Retraction Problem
1
1
Material Separation
1
1
Structural Problem
1
1
Mechanics Altered
1
1
Excess Flow or Over-Infusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
140
140
No Consequences Or Impact To Patient
124
124
No Known Impact Or Consequence To Patient
90
90
Insufficient Information
36
36
Missed Dose
14
14
Pain
8
8
Underdose
6
6
Hyperglycemia
6
6
Needle Stick/Puncture
5
5
Swelling
4
4
Bruise/Contusion
3
3
Reaction, Injection Site
3
3
Hypersensitivity/Allergic reaction
2
2
Bacterial Infection
2
2
Anxiety
2
2
Inflammation
2
2
Local Reaction
2
2
Erythema
2
2
Device Embedded In Tissue or Plaque
1
1
Hemorrhage/Bleeding
1
1
Tinnitus
1
1
Eye Injury
1
1
Dyspnea
1
1
Scar Tissue
1
1
Chest Pain
1
1
Irritation
1
1
Seroma
1
1
Injury
1
1
Foreign Body In Patient
1
1
Abrasion
1
1
Scarring
1
1
Obstruction/Occlusion
1
1
Blood Loss
1
1
Cataract
1
1
Necrosis
1
1
Sepsis
1
1
Skin Irritation
1
1
No Code Available
1
1
Arthralgia
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Abdominal Pain
1
1
High Blood Pressure/ Hypertension
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Owen Mumford USA, Inc.
II
Nov-01-2019
-
-