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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
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAFKAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIPPERT MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 10 10
2015 11 11
2016 8 8
2017 52 52
2018 76 76
2019 69 69
2020 88 88
2021 41 41
2022 11 11
2023 14 14
2024 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 174 174
Break 38 38
Contamination /Decontamination Problem 37 37
Leak/Splash 34 34
Contamination 23 23
Suction Problem 18 18
Appropriate Term/Code Not Available 18 18
Fluid/Blood Leak 16 16
Device Markings/Labelling Problem 15 15
Mechanical Problem 13 13
Detachment of Device or Device Component 11 11
Detachment Of Device Component 11 11
Physical Resistance/Sticking 10 10
Device Damaged Prior to Use 9 9
Disconnection 7 7
Material Fragmentation 6 6
Expiration Date Error 6 6
Suction Failure 5 5
Failure to Deliver 5 5
Connection Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Decrease in Suction 5 5
Packaging Problem 5 5
Defective Device 4 4
Loose or Intermittent Connection 4 4
Volume Accuracy Problem 4 4
Fitting Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Defective Component 4 4
Material Discolored 4 4
Device Operates Differently Than Expected 4 4
Tear, Rip or Hole in Device Packaging 3 3
Delivered as Unsterile Product 3 3
Use of Device Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Material Separation 3 3
Device Disinfection Or Sterilization Issue 3 3
Output Problem 3 3
Crack 2 2
Fungus in Device Environment 2 2
Device Packaging Compromised 2 2
Unsealed Device Packaging 2 2
Material Deformation 2 2
Device Contamination With Biological Material 2 2
Component Missing 2 2
Particulates 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Puncture/Hole 2 2
Misassembled 2 2
Device Inoperable 2 2
Infusion or Flow Problem 2 2
Physical Resistance 1 1
Inflation Problem 1 1
Device Reprocessing Problem 1 1
Burst Container or Vessel 1 1
Improper or Incorrect Procedure or Method 1 1
Material Integrity Problem 1 1
Unstable 1 1
Device Fell 1 1
Device Contamination with Body Fluid 1 1
Display Difficult to Read 1 1
Occlusion Within Device 1 1
Failure to Seal 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Structural Problem 1 1
Melted 1 1
Sticking 1 1
Pressure Problem 1 1
Failure to Clean Adequately 1 1
Partial Blockage 1 1
Contamination of Device Ingredient or Reagent 1 1
Out-Of-Box Failure 1 1
Application Program Problem: Medication Error 1 1
Protective Measures Problem 1 1
Patient Device Interaction Problem 1 1
Device Emits Odor 1 1
Hole In Material 1 1
Incomplete or Missing Packaging 1 1
Difficult to Advance 1 1
Inability to Irrigate 1 1
Flaked 1 1
Biocompatibility 1 1
Component Falling 1 1
Entrapment of Device 1 1
Moisture Damage 1 1
Material Too Soft/Flexible 1 1
Microbial Contamination of Device 1 1
Ejection Problem 1 1
Gel Leak 1 1
Filling Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 216 216
No Clinical Signs, Symptoms or Conditions 129 129
No Patient Involvement 100 100
No Consequences Or Impact To Patient 56 56
No Information 23 23
Foreign Body In Patient 9 9
Insufficient Information 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Exposure to Body Fluids 4 4
Burn(s) 3 3
Pain 3 3
Unspecified Infection 2 2
Skin Tears 2 2
Bacterial Infection 2 2
Urinary Tract Infection 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1
Discomfort 1 1
Fungal Infection 1 1
Fever 1 1
Numbness 1 1
Vitreous Floaters 1 1
Abrasion 1 1
Thrombosis/Thrombus 1 1
Pelvic Inflammatory Disease 1 1
Aspiration/Inhalation 1 1
Visual Impairment 1 1
No Code Available 1 1
Tissue Damage 1 1
Nausea 1 1
Meningitis 1 1
Unspecified Kidney or Urinary Problem 1 1
Complaint, Ill-Defined 1 1
Muscle Weakness 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 Cardinal Health 200, LLC I Feb-16-2024
5 Cook Inc. II Mar-26-2018
6 Customed, Inc II Apr-14-2016
7 Customed, Inc II Sep-03-2015
8 Customed, Inc II Mar-21-2012
9 Haemacure Corporation II May-11-2012
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
11 Medtronic Neurosurgery II Jul-25-2013
12 Micromedics, Inc. I Nov-18-2010
13 Shippert Medical Technologies II Aug-22-2017
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