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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
2019 69 69
2020 88 88
2021 41 41
2022 11 11
2023 14 14
2024 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 97 97
Contamination /Decontamination Problem 32 32
Leak/Splash 32 32
Break 19 19
Suction Problem 17 17
Contamination 15 15
Fluid/Blood Leak 14 14
Appropriate Term/Code Not Available 14 14
Mechanical Problem 11 11
Device Markings/Labelling Problem 10 10
Physical Resistance/Sticking 9 9
Device Damaged Prior to Use 8 8
Detachment of Device or Device Component 8 8
Decrease in Suction 5 5
Suction Failure 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Packaging Problem 4 4
Connection Problem 4 4
Defective Device 4 4
Defective Component 4 4
Volume Accuracy Problem 4 4
Failure to Deliver 4 4
Tear, Rip or Hole in Device Packaging 3 3
Material Separation 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Output Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Use of Device Problem 2 2
Particulates 2 2
Material Puncture/Hole 2 2
Crack 2 2
Component Missing 2 2
Infusion or Flow Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Partial Blockage 1 1
Biocompatibility 1 1
Incomplete or Missing Packaging 1 1
Device Contamination with Body Fluid 1 1
Structural Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Display Difficult to Read 1 1
Filling Problem 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inability to Irrigate 1 1
Melted 1 1
Misassembled 1 1
Moisture Damage 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Material Deformation 1 1
Failure to Clean Adequately 1 1
Failure to Seal 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Material Too Soft/Flexible 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 126 126
No Known Impact Or Consequence To Patient 117 117
No Patient Involvement 67 67
No Consequences Or Impact To Patient 34 34
Insufficient Information 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Foreign Body In Patient 6 6
No Information 3 3
No Code Available 1 1
Unspecified Kidney or Urinary Problem 1 1
Discomfort 1 1
Meningitis 1 1
Numbness 1 1
Fungal Infection 1 1
Abrasion 1 1
Aspiration/Inhalation 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Infection 1 1
Muscle Weakness 1 1
Nausea 1 1
Pain 1 1
Pelvic Inflammatory Disease 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
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