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TPLC
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show TPLC since
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Device
syringe, irrigating (non dental)
Product Code
KYZ
Regulation Number
880.6960
Device Class
1
Premarket Reviews
Manufacturer
Decision
SAFKAN, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
76
76
2019
69
69
2020
88
88
2021
41
41
2022
11
11
2023
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contamination with Chemical or Other Material
141
141
Contamination /Decontamination Problem
36
36
Break
27
27
Leak/Splash
25
25
Fluid/Blood Leak
13
13
Device Markings/Labelling Problem
11
11
Physical Resistance/Sticking
10
10
Contamination
10
10
Suction Problem
9
9
Device Damaged Prior to Use
8
8
Detachment Of Device Component
7
7
Material Fragmentation
6
6
Decrease in Suction
5
5
Failure to Deliver
5
5
Suction Failure
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Detachment of Device or Device Component
5
5
Defective Device
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Packaging Problem
4
4
Appropriate Term/Code Not Available
4
4
Defective Component
4
4
Volume Accuracy Problem
4
4
Tear, Rip or Hole in Device Packaging
3
3
Material Discolored
3
3
Output Problem
3
3
Material Deformation
2
2
Device Contaminated During Manufacture or Shipping
2
2
Fungus in Device Environment
2
2
Therapeutic or Diagnostic Output Failure
2
2
Mechanical Problem
2
2
Component Missing
2
2
Particulates
2
2
Material Puncture/Hole
2
2
Use of Device Problem
2
2
Misassembled
2
2
Moisture Damage
1
1
Delivered as Unsterile Product
1
1
Unsealed Device Packaging
1
1
Improper or Incorrect Procedure or Method
1
1
Incomplete or Missing Packaging
1
1
Structural Problem
1
1
Physical Resistance
1
1
Melted
1
1
Loose or Intermittent Connection
1
1
Gel Leak
1
1
Labelling, Instructions for Use or Training Problem
1
1
Inability to Irrigate
1
1
Disconnection
1
1
Filling Problem
1
1
Flaked
1
1
Component Falling
1
1
Device Reprocessing Problem
1
1
Partial Blockage
1
1
Protective Measures Problem
1
1
Patient Device Interaction Problem
1
1
Component Misassembled
1
1
Ejection Problem
1
1
Failure to Clean Adequately
1
1
Device Fell
1
1
Device Contamination with Body Fluid
1
1
Biocompatibility
1
1
Device Contamination With Biological Material
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Operates Differently Than Expected
1
1
Difficult to Advance
1
1
Material Integrity Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
170
170
No Patient Involvement
95
95
No Clinical Signs, Symptoms or Conditions
53
53
No Consequences Or Impact To Patient
52
52
Foreign Body In Patient
8
8
Insufficient Information
7
7
No Information
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Unspecified Infection
2
2
Pain
2
2
Pelvic Inflammatory Disease
1
1
Urinary Tract Infection
1
1
Visual Impairment
1
1
Abrasion
1
1
Aspiration/Inhalation
1
1
Bacterial Infection
1
1
Exposure to Body Fluids
1
1
Vitreous Floaters
1
1
Hemorrhage/Bleeding
1
1
Low Blood Pressure/ Hypotension
1
1
Muscle Weakness
1
1
Nausea
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Meningitis
1
1
Numbness
1
1
Fungal Infection
1
1
No Code Available
1
1
Unspecified Kidney or Urinary Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Mar-01-2018
2
Cook Inc.
II
Mar-26-2018
3
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-10-2023
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