• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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

MDR Year MDR Reports MDR Events
2020 88 88
2021 41 41
2022 11 11
2023 14 14
2024 106 106
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 66 66
Leak/Splash 27 27
Contamination /Decontamination Problem 21 21
Appropriate Term/Code Not Available 20 20
Suction Problem 17 17
Contamination 16 16
Fluid/Blood Leak 13 13
Break 13 13
Mechanical Problem 11 11
Detachment of Device or Device Component 8 8
Device Damaged Prior to Use 7 7
Device Markings/Labelling Problem 7 7
Physical Resistance/Sticking 6 6
Connection Problem 4 4
Suction Failure 4 4
Packaging Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Defective Component 4 4
Defective Device 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Failure to Deliver 4 4
Tear, Rip or Hole in Device Packaging 3 3
Material Separation 3 3
Decrease in Suction 3 3
Insufficient Information 3 3
Crack 3 3
Output Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Moisture Damage 2 2
Material Integrity Problem 2 2
Use of Device Problem 2 2
Infusion or Flow Problem 2 2
Material Split, Cut or Torn 2 2
Device Contaminated During Manufacture or Shipping 2 2
Failure to Clean Adequately 1 1
Unsealed Device Packaging 1 1
Patient Device Interaction Problem 1 1
Ejection Problem 1 1
Inability to Irrigate 1 1
Filling Problem 1 1
Partial Blockage 1 1
Labelling, Instructions for Use or Training Problem 1 1
Display Difficult to Read 1 1
Device Contamination with Body Fluid 1 1
Component Misassembled 1 1
Volume Accuracy Problem 1 1
Melted 1 1
Pressure Problem 1 1
Material Too Soft/Flexible 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 154 154
No Known Impact Or Consequence To Patient 59 59
No Patient Involvement 38 38
No Consequences Or Impact To Patient 20 20
Insufficient Information 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Infection 3 3
Foreign Body In Patient 3 3
Fever 2 2
Exposure to Body Fluids 2 2
Pain 2 2
Fungal Infection 1 1
Muscle Weakness 1 1
Pelvic Inflammatory Disease 1 1
Thrombosis/Thrombus 1 1
Discomfort 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 Sep-30-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
-
-