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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 94 94

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 99 99
Contamination /Decontamination Problem 33 33
Leak/Splash 32 32
Break 20 20
Appropriate Term/Code Not Available 19 19
Suction Problem 17 17
Contamination 16 16
Fluid/Blood Leak 14 14
Device Markings/Labelling Problem 12 12
Mechanical Problem 11 11
Physical Resistance/Sticking 9 9
Detachment of Device or Device Component 8 8
Device Damaged Prior to Use 8 8
Manufacturing, Packaging or Shipping Problem 5 5
Suction Failure 5 5
Decrease in Suction 5 5
Connection Problem 4 4
Defective Component 4 4
Volume Accuracy Problem 4 4
Defective Device 4 4
Packaging 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
Moisture Damage 2 2
Particulates 2 2
Material Puncture/Hole 2 2
Infusion or Flow Problem 2 2
Crack 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Split, Cut or Torn 2 2
Use of Device Problem 2 2
Component Missing 2 2
Ejection Problem 1 1
Patient Device Interaction Problem 1 1
Material Fragmentation 1 1
Filling Problem 1 1
Structural Problem 1 1
Inability to Irrigate 1 1
Misassembled 1 1
Material Deformation 1 1
Delivered as Unsterile Product 1 1
Display Difficult to Read 1 1
Insufficient Information 1 1
Device Contamination with Body Fluid 1 1
Incomplete or Missing Packaging 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 138 138
No Known Impact Or Consequence To Patient 117 117
No Patient Involvement 67 67
No Consequences Or Impact To Patient 34 34
Insufficient Information 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Foreign Body In Patient 6 6
No Information 3 3
Exposure to Body Fluids 3 3
Pain 3 3
Unspecified Infection 1 1
Nausea 1 1
Fungal Infection 1 1
No Code Available 1 1
Aspiration/Inhalation 1 1
Muscle Weakness 1 1
Abrasion 1 1
Pelvic Inflammatory Disease 1 1
Thrombosis/Thrombus 1 1
Discomfort 1 1
Numbness 1 1
Unspecified Kidney or Urinary Problem 1 1
Bacterial Infection 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 Feb-10-2023
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