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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
ELCAM MEDICAL A.C.A.L.
SUBSTANTIALLY EQUIVALENT
1
EMED TECHNOLOGIES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC MINIMED
SUBSTANTIALLY EQUIVALENT
1
OWEN MUMFORD, LTD.
SUBSTANTIALLY EQUIVALENT
1
SCANDINAVIAN HEALTH LIMITED
SUBSTANTIALLY EQUIVALENT
2
YPSOMED AG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
138
138
2015
99
99
2016
68
68
2017
88
88
2018
88
88
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
326
326
Misfire
195
195
Break
47
47
Bent
42
42
Sticking
33
33
Device Operates Differently Than Expected
32
32
Defective Device
25
25
Failure to Deliver
22
22
Insufficient Information
18
18
Physical Resistance/Sticking
17
17
Mechanical Jam
16
16
Device Displays Incorrect Message
13
13
Defective Component
13
13
Adverse Event Without Identified Device or Use Problem
13
13
Therapeutic or Diagnostic Output Failure
12
12
Difficult to Insert
12
12
Fluid/Blood Leak
10
10
Leak/Splash
9
9
Improper or Incorrect Procedure or Method
9
9
Material Twisted/Bent
9
9
Output Problem
8
8
Component Missing
7
7
Mechanical Problem
6
6
Kinked
5
5
Device Inoperable
5
5
Inaccurate Delivery
5
5
Activation, Positioning or Separation Problem
5
5
Patient-Device Incompatibility
5
5
Fitting Problem
5
5
Use of Device Problem
4
4
High Test Results
4
4
Occlusion Within Device
4
4
Detachment Of Device Component
4
4
Device Alarm System
4
4
Failure To Adhere Or Bond
3
3
Difficult to Remove
3
3
Device Slipped
3
3
Failure to Infuse
3
3
Dull, Blunt
3
3
Appropriate Term/Code Not Available
3
3
Ejection Problem
3
3
Failure to Eject
2
2
Noise, Audible
2
2
Key or Button Unresponsive/not Working
2
2
Packaging Problem
2
2
Positioning Problem
2
2
Naturally Worn
2
2
Insufficient Flow or Under Infusion
2
2
Failure to Fire
2
2
Connection Problem
2
2
Detachment of Device or Device Component
2
2
Improper Flow or Infusion
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Retraction Problem
2
2
Air Leak
2
2
Shipping Damage or Problem
2
2
Loss of or Failure to Bond
2
2
Component Falling
2
2
Crack
2
2
Difficult or Delayed Positioning
1
1
Disconnection
1
1
Entrapment of Device
1
1
Use of Incorrect Control/Treatment Settings
1
1
Excess Flow or Over-Infusion
1
1
Burst Container or Vessel
1
1
Device Reprocessing Problem
1
1
Complete Blockage
1
1
Material Separation
1
1
Unstable
1
1
Unexpected Therapeutic Results
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Device Difficult to Setup or Prepare
1
1
Failure to Prime
1
1
Mechanics Altered
1
1
Moisture or Humidity Problem
1
1
Inadequate User Interface
1
1
Calibration Problem
1
1
Device Operational Issue
1
1
Device Packaging Compromised
1
1
Device-Device Incompatibility
1
1
Separation Failure
1
1
Structural Problem
1
1
Device Contamination with Body Fluid
1
1
Obstruction of Flow
1
1
No Flow
1
1
No Apparent Adverse Event
1
1
Protective Measures Problem
1
1
Activation Problem
1
1
Firing Problem
1
1
Device Handling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
341
341
No Known Impact Or Consequence To Patient
180
180
Hyperglycemia
146
146
No Clinical Signs, Symptoms or Conditions
129
129
Insufficient Information
34
34
Missed Dose
15
15
Hypoglycemia
15
15
Diabetic Ketoacidosis
11
11
Pain
10
10
Needle Stick/Puncture
8
8
Underdose
8
8
Aneurysm
7
7
No Information
6
6
Swelling
5
5
Reaction, Injection Site
4
4
No Code Available
3
3
Loss of consciousness
3
3
Injury
3
3
Unspecified Infection
3
3
Inflammation
3
3
Bruise/Contusion
3
3
Bacterial Infection
2
2
Hypersensitivity/Allergic reaction
2
2
Headache
2
2
Hemorrhage/Bleeding
2
2
Dyspnea
2
2
Erythema
2
2
Local Reaction
2
2
Itching Sensation
2
2
Nausea
2
2
Scarring
2
2
Overdose
2
2
Anxiety
2
2
No Patient Involvement
2
2
Alteration In Body Temperature
1
1
Foreign Body In Patient
1
1
Device Embedded In Tissue or Plaque
1
1
Blood Loss
1
1
Urinary Frequency
1
1
Arthralgia
1
1
Obstruction/Occlusion
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Sepsis
1
1
Seroma
1
1
Skin Irritation
1
1
Tinnitus
1
1
Vomiting
1
1
Weakness
1
1
Burning Sensation
1
1
Necrosis
1
1
Scar Tissue
1
1
Irritation
1
1
Eye Injury
1
1
Fainting
1
1
Fever
1
1
High Blood Pressure/ Hypertension
1
1
Abdominal Pain
1
1
Abrasion
1
1
Cataract
1
1
Chest Pain
1
1
Purulent Discharge
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Company
II
Nov-07-2011
2
International Medsurg Connection, Inc.
II
Aug-04-2017
3
Owen Mumford USA, Inc.
II
Nov-01-2019
4
Owen Mumford USA, Inc.
II
Apr-02-2015
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