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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, irrigating (non dental)
Product CodeKYZ
Regulation Number 880.6960
Device Class 1


Premarket Reviews
ManufacturerDecision
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 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 140 140
Contamination /Decontamination Problem 36 36
Break 27 27
Leak/Splash 25 25
Fluid/Blood Leak 13 13
Device Markings/Labelling Problem 11 11
Contamination 10 10
Suction Problem 9 9
Physical Resistance/Sticking 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
Defective Component 4 4
Volume Accuracy Problem 4 4
Tear, Rip or Hole in Device Packaging 3 3
Material Discolored 3 3
Appropriate Term/Code Not Available 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 Consequences Or Impact To Patient 52 52
No Clinical Signs, Symptoms or Conditions 50 50
Foreign Body In Patient 8 8
Insufficient Information 7 7
No Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
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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