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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)
Regulation Description Irrigating syringe.
Product CodeKYZ
Regulation Number 880.6960
Device Class 1

MDR Year MDR Reports MDR Events
2021 41 41
2022 11 11
2023 14 15
2024 106 107
2025 28 28
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 34 34
Contamination 21 21
Appropriate Term/Code Not Available 20 20
Leak/Splash 17 17
Break 13 13
Suction Problem 11 11
Mechanical Problem 11 11
Detachment of Device or Device Component 10 10
Fluid/Blood Leak 5 5
Device Markings/Labelling Problem 5 5
Insufficient Information 5 5
Packaging Problem 5 5
Contamination /Decontamination Problem 5 5
Connection Problem 4 4
Physical Resistance/Sticking 4 4
Material Separation 4 4
Infusion or Flow Problem 3 3
Failure to Deliver 3 3
Crack 3 3
Moisture Damage 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Split, Cut or Torn 2 3
Failure to Clean Adequately 1 1
Patient Device Interaction Problem 1 2
Material Too Rigid or Stiff 1 1
Use of Device Problem 1 1
Decrease in Suction 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Device 1 1
Partial Blockage 1 1
Device Damaged Prior to Use 1 1
Display Difficult to Read 1 1
Melted 1 1
Nonstandard Device 1 1
Pressure Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Too Soft/Flexible 1 1
Loose or Intermittent Connection 1 1
Disconnection 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 167 168
Insufficient Information 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Patient Involvement 5 5
Foreign Body In Patient 4 4
No Consequences Or Impact To Patient 4 4
Unspecified Infection 3 3
Exposure to Body Fluids 3 3
Fever 2 2
Pain 2 2
Fungal Infection 1 1
Muscle Weakness 1 1
Pelvic Inflammatory Disease 1 2
Thrombosis/Thrombus 1 1
Unspecified Kidney or Urinary Problem 1 1
Meningitis 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-30-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
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