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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
2018 180 180
2019 200 207
2020 202 202
2021 216 216
2022 96 96
2023 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Break 169 173
Disconnection 132 132
Dull, Blunt 99 99
Suction Failure 91 91
Suction Problem 89 89
Inflation Problem 70 70
Detachment of Device or Device Component 67 67
Material Fragmentation 54 54
Device Contamination with Chemical or Other Material 50 53
Fluid/Blood Leak 38 38
Burst Container or Vessel 28 28
Leak/Splash 22 22
Fracture 18 18
Component Missing 17 17
Fitting Problem 15 15
Difficult to Remove 15 15
Material Split, Cut or Torn 15 15
Material Rupture 14 14
Crack 13 13
Pressure Problem 12 12
Therapeutic or Diagnostic Output Failure 11 11
Entrapment of Device 11 11
Product Quality Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Contamination /Decontamination Problem 10 10
Device Damaged Prior to Use 9 9
Detachment Of Device Component 9 9
Incorrect Measurement 9 9
Physical Resistance/Sticking 9 9
Device Operates Differently Than Expected 8 8
Partial Blockage 8 8
Decrease in Suction 8 8
Material Separation 8 8
Component Misassembled 7 7
Gas/Air Leak 6 6
Complete Blockage 6 6
Restricted Flow rate 5 5
Loose or Intermittent Connection 5 5
Misassembled 5 5
Delivered as Unsterile Product 5 5
Material Puncture/Hole 5 5
Obstruction of Flow 5 5
Tear, Rip or Hole in Device Packaging 5 5
Defective Device 5 5
Appropriate Term/Code Not Available 5 5
No Apparent Adverse Event 4 4
Insufficient Information 4 4
Difficult to Open or Close 4 4
Material Deformation 4 4
Material Twisted/Bent 4 4
Use of Device Problem 4 4
Difficult to Insert 4 4
Collapse 4 4
Deflation Problem 3 3
Deformation Due to Compressive Stress 3 3
No Flow 3 3
Output Problem 3 3
Packaging Problem 3 3
Device Fell 3 3
Device Markings/Labelling Problem 3 3
Noise, Audible 2 2
Torn Material 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Integrity Problem 2 2
Infusion or Flow Problem 2 2
Connection Problem 2 2
Structural Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Infuse 2 2
Inadequate Instructions for Healthcare Professional 2 2
Contamination 2 2
Unsealed Device Packaging 2 2
Nonstandard Device 2 2
No Device Output 1 1
Decrease in Pressure 1 1
Material Frayed 1 1
Hole In Material 1 1
Migration or Expulsion of Device 1 1
Unintended Ejection 1 1
Inaccurate Flow Rate 1 1
Backflow 1 1
Component Falling 1 1
Out-Of-Box Failure 1 1
Defective Component 1 1
Insufficient Flow or Under Infusion 1 1
Device Slipped 1 1
Device Inoperable 1 1
Self-Activation or Keying 1 1
Failure to Advance 1 1
Split 1 1
Failure to Cut 1 1
Malposition of Device 1 1
Biocompatibility 1 1
Blocked Connection 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination With Biological Material 1 1
Cut In Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Incorrect Device Or Component Shipped 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 347 347
No Clinical Signs, Symptoms or Conditions 341 341
No Known Impact Or Consequence To Patient 313 313
No Patient Involvement 112 115
Foreign Body In Patient 95 95
Insufficient Information 29 29
Device Embedded In Tissue or Plaque 26 26
No Information 21 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
No Code Available 12 12
Exposure to Body Fluids 12 12
Unspecified Infection 12 12
Patient Problem/Medical Problem 11 11
Hematoma 10 10
Post Operative Wound Infection 7 7
Pain 6 6
Injury 3 3
Tissue Damage 2 2
Impaired Healing 2 2
Skin Irritation 2 2
Fever 2 2
Irritation 2 2
Laceration(s) 2 2
Bruise/Contusion 2 2
Edema 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abdominal Pain 1 1
Abscess 1 1
Hemorrhage/Bleeding 1 1
Hemorrhage, Subdural 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Necrosis 1 1
Foreign Body Sensation in Eye 1 1
Pneumothorax 1 1
Sepsis 1 1
Swelling 1 1
Discomfort 1 1
Fasciitis 1 1
Blood Loss 1 1
Joint Laxity 1 1
Skin Inflammation/ Irritation 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Dec-21-2018
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