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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


Premarket Reviews
ManufacturerDecision
SAFKAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K201877  OtoSet- Ear Cleaning System

MDR Year MDR Reports MDR Events
2020 88 88
2021 41 41
2022 11 11
2023 14 14
2024 106 106
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 65 65
Leak/Splash 27 27
Appropriate Term/Code Not Available 20 20
Contamination /Decontamination Problem 20 20
Suction Problem 17 17
Contamination 15 15
Break 13 13
Fluid/Blood Leak 13 13
Mechanical Problem 11 11
Detachment of Device or Device Component 8 8
Device Damaged Prior to Use 7 7
Physical Resistance/Sticking 6 6
Device Markings/Labelling Problem 6 6
Defective Component 4 4
Defective Device 4 4
Suction Failure 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Packaging Problem 4 4
Connection Problem 4 4
Failure to Deliver 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Separation 3 3
Output Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Decrease in Suction 3 3
Insufficient Information 3 3
Crack 3 3
Infusion or Flow Problem 2 2
Moisture Damage 2 2
Device Contaminated During Manufacture or Shipping 2 2
Use of Device Problem 2 2
Material Integrity Problem 2 2
Material Split, Cut or Torn 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unsealed Device Packaging 1 1
Biocompatibility 1 1
Failure to Clean Adequately 1 1
Ejection Problem 1 1
Patient Device Interaction Problem 1 1
Volume Accuracy Problem 1 1
Partial Blockage 1 1
Filling Problem 1 1
Pressure Problem 1 1
Inability to Irrigate 1 1
Device Contamination with Body Fluid 1 1
Material Too Soft/Flexible 1 1
Display Difficult to Read 1 1
Failure to Seal 1 1
Melted 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 150 150
No Known Impact Or Consequence To Patient 59 59
No Patient Involvement 38 38
No Consequences Or Impact To Patient 20 20
Insufficient Information 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Infection 3 3
Foreign Body In Patient 3 3
Exposure to Body Fluids 2 2
Fever 2 2
Pain 2 2
Bacterial Infection 1 1
Low Blood Pressure/ Hypotension 1 1
Muscle Weakness 1 1
Pelvic Inflammatory Disease 1 1
Discomfort 1 1
Meningitis 1 1
Fungal Infection 1 1
Thrombosis/Thrombus 1 1
Unspecified Kidney or Urinary Problem 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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