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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 76 76

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 36 36
Leak/Splash 34 34
Contamination 23 23
Suction Problem 18 18
Fluid/Blood Leak 16 16
Appropriate Term/Code Not Available 16 16
Device Markings/Labelling Problem 15 15
Mechanical Problem 13 13
Detachment Of Device Component 11 11
Detachment of Device or 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
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
Suction Failure 5 5
Material Discolored 4 4
Loose or Intermittent Connection 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Device Operates Differently Than Expected 4 4
Defective Device 4 4
Defective Component 4 4
Fitting Problem 4 4
Volume Accuracy Problem 4 4
Tear, Rip or Hole in Device Packaging 3 3
Output Problem 3 3
Device Disinfection Or Sterilization Issue 3 3
Device Contaminated During Manufacture or Shipping 3 3
Delivered as Unsterile Product 3 3
Material Separation 3 3
Use of Device Problem 3 3
Device Inoperable 2 2
Unsealed Device Packaging 2 2
Particulates 2 2
Material Puncture/Hole 2 2
Misassembled 2 2
Crack 2 2
Infusion or Flow Problem 2 2
Material Deformation 2 2
Device Packaging Compromised 2 2
Device Contamination With Biological Material 2 2
Fungus in Device Environment 2 2
Component Missing 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Clean Adequately 1 1
Failure to Seal 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Device Fell 1 1
Application Program Problem: Medication Error 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Material Too Soft/Flexible 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Microbial Contamination of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Device Contamination with Body Fluid 1 1
Structural Problem 1 1
Biocompatibility 1 1
Physical Resistance 1 1
Contamination of Device Ingredient or Reagent 1 1
Difficult to Advance 1 1
Material Integrity Problem 1 1
Component Falling 1 1
Burst Container or Vessel 1 1
Device Reprocessing Problem 1 1
Gel Leak 1 1
Hole In Material 1 1
Inflation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inability to Irrigate 1 1
Display Difficult to Read 1 1
Entrapment of Device 1 1
Filling Problem 1 1
Flaked 1 1
Moisture Damage 1 1
Occlusion Within Device 1 1
Device Emits Odor 1 1
Melted 1 1
Device Slipped 1 1
Sticking 1 1
Unstable 1 1
Partial Blockage 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 126 126
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
Pain 3 3
Burn(s) 3 3
Bacterial Infection 2 2
Exposure to Body Fluids 2 2
Skin Tears 2 2
Unspecified Infection 2 2
Muscle Weakness 1 1
Nausea 1 1
No Code Available 1 1
Unspecified Kidney or Urinary Problem 1 1
Abrasion 1 1
Aspiration/Inhalation 1 1
Fever 1 1
Vitreous Floaters 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1
Pelvic Inflammatory Disease 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Visual Impairment 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Meningitis 1 1
Numbness 1 1
Fungal Infection 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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