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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, suction, single patient use, portable, nonpowered
Product CodeGCY
Regulation Number 878.4680
Device Class 1

MDR Year MDR Reports MDR Events
2019 200 207
2020 202 202
2021 216 216
2022 96 96
2023 92 92
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 130 134
Disconnection 115 115
Dull, Blunt 102 102
Suction Failure 93 93
Detachment of Device or Device Component 58 58
Material Fragmentation 54 54
Suction Problem 51 51
Device Contamination with Chemical or Other Material 49 52
Inflation Problem 47 47
Fluid/Blood Leak 34 34
Burst Container or Vessel 20 20
Fracture 16 16
Fitting Problem 16 16
Leak/Splash 15 15
Material Split, Cut or Torn 15 15
Difficult to Remove 13 13
Component Missing 13 13
Material Rupture 12 12
Pressure Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Product Quality Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Entrapment of Device 10 10
Crack 10 10
Incorrect Measurement 9 9
Material Separation 8 8
Decrease in Suction 8 8
Contamination /Decontamination Problem 8 8
Device Damaged Prior to Use 8 8
Partial Blockage 7 7
Physical Resistance/Sticking 7 7
Component Misassembled 7 7
Tear, Rip or Hole in Device Packaging 6 6
Gas/Air Leak 6 6
Defective Device 5 5
Restricted Flow rate 5 5
Complete Blockage 4 4
Use of Device Problem 4 4
Material Puncture/Hole 4 4
Misassembled 4 4
Delivered as Unsterile Product 4 4
Difficult to Insert 4 4
Material Twisted/Bent 4 4
No Apparent Adverse Event 4 4
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Device Fell 3 3
Output Problem 3 3
Material Deformation 3 3
Difficult to Open or Close 3 3
Obstruction of Flow 3 3
Loose or Intermittent Connection 3 3
Unsealed Device Packaging 3 3
Collapse 3 3
Inadequate Instructions for Healthcare Professional 2 2
Inadequacy of Device Shape and/or Size 2 2
Structural Problem 2 2
Failure to Infuse 2 2
Deformation Due to Compressive Stress 2 2
Connection Problem 2 2
Device Markings/Labelling Problem 2 2
Packaging Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Missing Information 1 1
Explosion 1 1
Material Too Soft/Flexible 1 1
Noise, Audible 1 1
No Pressure 1 1
No Flow 1 1
Scratched Material 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Infusion or Flow Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Malposition of Device 1 1
Biocompatibility 1 1
Failure to Advance 1 1
Defective Component 1 1
Insufficient Flow or Under Infusion 1 1
Self-Activation or Keying 1 1
Decrease in Pressure 1 1
Contamination 1 1
Backflow 1 1
Deflation Problem 1 1
Inaccurate Flow Rate 1 1
Unintended Ejection 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 373 373
No Consequences Or Impact To Patient 275 275
No Known Impact Or Consequence To Patient 200 200
Foreign Body In Patient 81 81
No Patient Involvement 65 68
Insufficient Information 29 29
Device Embedded In Tissue or Plaque 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Exposure to Body Fluids 12 12
Unspecified Infection 11 11
Patient Problem/Medical Problem 11 11
Hematoma 8 8
Post Operative Wound Infection 7 7
No Information 6 10
Pain 5 5
No Code Available 4 4
Injury 3 3
Irritation 2 2
Laceration(s) 2 2
Bruise/Contusion 2 2
Unspecified Tissue Injury 2 2
Fever 1 1
Foreign Body Sensation in Eye 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Abdominal Pain 1 1
Abscess 1 1
Pneumothorax 1 1
Skin Irritation 1 1
Tissue Damage 1 1
Impaired Healing 1 1
Discomfort 1 1
Blood Loss 1 1
Fluid Discharge 1 1
Joint Laxity 1 1
Skin Inflammation/ Irritation 1 1

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