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TPLC
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show TPLC since
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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
7
7
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
Fluid/Blood Leak
9
9
Material Twisted/Bent
9
9
Output Problem
8
8
Adverse Event Without Identified Device or Use Problem
5
5
Leak/Splash
5
5
Mechanical Problem
5
5
Activation, Positioning or Separation Problem
5
5
Insufficient Information
4
4
Ejection Problem
3
3
Use of Device Problem
3
3
Inaccurate Delivery
3
3
Failure to Infuse
3
3
Dull, Blunt
3
3
Device Slipped
3
3
Difficult to Remove
2
2
Detachment of Device or Device Component
2
2
Improper Flow or Infusion
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Failure to Fire
2
2
Patient-Device Incompatibility
2
2
Failure to Eject
2
2
Packaging Problem
2
2
Insufficient Flow or Under Infusion
2
2
Key or Button Unresponsive/not Working
2
2
Mechanics Altered
1
1
Naturally Worn
1
1
No Flow
1
1
Firing Problem
1
1
Activation Problem
1
1
Noise, Audible
1
1
No Apparent Adverse Event
1
1
Connection Problem
1
1
Device-Device Incompatibility
1
1
Obstruction of Flow
1
1
Structural Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Component Missing
1
1
Retraction Problem
1
1
Material Separation
1
1
Shipping Damage or Problem
1
1
Unexpected Therapeutic Results
1
1
Device Alarm System
1
1
Loss of or Failure to Bond
1
1
Excess Flow or Over-Infusion
1
1
Difficult to Insert
1
1
Burst Container or Vessel
1
1
Complete Blockage
1
1
Use of Incorrect Control/Treatment Settings
1
1
Crack
1
1
Disconnection
1
1
Entrapment of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
129
129
No Consequences Or Impact To Patient
124
124
No Known Impact Or Consequence To Patient
90
90
Insufficient Information
34
34
Missed Dose
14
14
Pain
8
8
Hyperglycemia
6
6
Underdose
6
6
Needle Stick/Puncture
5
5
Swelling
4
4
Reaction, Injection Site
3
3
Bruise/Contusion
3
3
Erythema
2
2
Hypersensitivity/Allergic reaction
2
2
Inflammation
2
2
Local Reaction
2
2
Bacterial Infection
2
2
Anxiety
2
2
Injury
1
1
Arthralgia
1
1
Obstruction/Occlusion
1
1
Tinnitus
1
1
Blood Loss
1
1
Foreign Body In Patient
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Device Embedded In Tissue or Plaque
1
1
No Code Available
1
1
Scar Tissue
1
1
Scarring
1
1
Sepsis
1
1
Seroma
1
1
Skin Irritation
1
1
Irritation
1
1
Necrosis
1
1
High Blood Pressure/ Hypertension
1
1
Eye Injury
1
1
Hemorrhage/Bleeding
1
1
Abdominal Pain
1
1
Abrasion
1
1
Cataract
1
1
Chest Pain
1
1
Dyspnea
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Owen Mumford USA, Inc.
II
Nov-01-2019
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