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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
5
5
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
Leak/Splash
5
5
Activation, Positioning or Separation Problem
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Insufficient Information
4
4
Inaccurate Delivery
3
3
Device Slipped
3
3
Ejection Problem
3
3
Dull, Blunt
3
3
Failure to Infuse
3
3
Use of Device Problem
3
3
Failure to Eject
2
2
Key or Button Unresponsive/not Working
2
2
Difficult to Remove
2
2
Patient-Device Incompatibility
2
2
Failure to Fire
2
2
Insufficient Flow or Under Infusion
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Improper Flow or Infusion
2
2
Packaging Problem
2
2
Detachment of Device or Device Component
2
2
Noise, Audible
1
1
Crack
1
1
Naturally Worn
1
1
Entrapment of Device
1
1
Difficult to Insert
1
1
Device Alarm System
1
1
Mechanics Altered
1
1
Firing Problem
1
1
Disconnection
1
1
Device-Device Incompatibility
1
1
Use of Incorrect Control/Treatment Settings
1
1
Material Separation
1
1
Excess Flow or Over-Infusion
1
1
Complete Blockage
1
1
Unexpected Therapeutic Results
1
1
Improper or Incorrect Procedure or Method
1
1
Burst Container or Vessel
1
1
Connection Problem
1
1
Loss of or Failure to Bond
1
1
Retraction Problem
1
1
Component Missing
1
1
No Flow
1
1
No Apparent Adverse Event
1
1
Activation Problem
1
1
Structural Problem
1
1
Obstruction of Flow
1
1
Shipping Damage or Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
128
128
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
4
4
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
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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