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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

MDR Year MDR Reports MDR Events
2016 8 8
2017 52 52
2018 76 76
2019 69 69
2020 88 88
2021 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 153 153
Contamination /Decontamination Problem 35 35
Break 27 27
Leak/Splash 20 20
Device Markings/Labelling Problem 13 13
Fluid Leak 13 13
Contamination 11 11
Suction Problem 9 9
Detachment Of Device Component 7 7
Device Damaged Prior to Use 7 7
Physical Resistance/Sticking 6 6
Material Fragmentation 6 6
Expiration Date Error 6 6
Suction Failure 5 5
Decrease in Suction 5 5
Material Discolored 4 4
Loose or Intermittent Connection 4 4
Defective Component 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Volume Accuracy Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Delivered as Unsterile Product 3 3
Device Disinfection Or Sterilization Issue 3 3
Defective Device 3 3
Output Problem 3 3
Use of Device Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Appropriate Term/Code Not Available 2 2
Detachment of Device or Device Component 2 2
Failure to Deliver 2 2
Component Missing 2 2
Mechanical Problem 2 2
Unsealed Device Packaging 2 2
Particulates 2 2
Material Puncture/Hole 2 2
Device Inoperable 2 2
Fungus in Device Environment 2 2
Misassembled 2 2
Material Deformation 2 2
Device Contaminated During Manufacture or Shipping 2 2
Tear, Rip or Hole in Device Packaging 2 2
Fitting Problem 2 2
Device Contamination With Biological Material 2 2
Contamination of Device Ingredient or Reagent 1 1
Biocompatibility 1 1
Improper or Incorrect Procedure or Method 1 1
Difficult to Advance 1 1
Material Integrity Problem 1 1
Component Misassembled 1 1
Component Falling 1 1
Disconnection 1 1
Entrapment of Device 1 1
Flaked 1 1
Inability to Irrigate 1 1
Device Contamination with Body Fluid 1 1
Unstable 1 1
Occlusion Within Device 1 1
Sticking 1 1
Device Fell 1 1
Device Slipped 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Gel Leak 1 1
Labelling, Instructions for Use or Training Problem 1 1
Burst Container or Vessel 1 1
Device Reprocessing Problem 1 1
Filling Problem 1 1
Structural Problem 1 1
Physical Resistance 1 1
Device Operates Differently Than Expected 1 1
Device Packaging Compromised 1 1
Application Program Problem: Medication Error 1 1
Ejection Problem 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 202 202
No Patient Involvement 100 100
No Consequences Or Impact To Patient 54 54
No Information 21 21
Foreign Body In Patient 6 6
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 3 3
Burn(s) 3 3
Pain 3 3
Skin Tears 2 2
Vitreous Floaters 1 1
Abrasion 1 1
Aspiration/Inhalation 1 1
Numbness 1 1
Urinary Tract Infection 1 1
Visual Impairment 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Nausea 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-01-2018
2 C.R. Bard, Inc. II Dec-12-2016
3 C.R. Bard, Inc. III Feb-16-2016
4 Cook Inc. II Mar-26-2018
5 Customed, Inc II Apr-14-2016
6 Shippert Medical Technologies II Aug-22-2017
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