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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
Regulation Description Nonpowered, single patient, portable suction apparatus.
Product CodeGCY
Regulation Number 878.4680
Device Class 1

MDR Year MDR Reports MDR Events
2020 202 202
2021 216 216
2022 96 96
2023 92 92
2024 75 75
2025 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 106 106
Dull, Blunt 106 106
Suction Failure 85 85
Break 69 69
Material Fragmentation 61 61
Device Contamination with Chemical or Other Material 55 55
Inflation Problem 30 30
Fluid/Blood Leak 26 26
Detachment of Device or Device Component 24 24
Suction Problem 24 24
Material Split, Cut or Torn 20 20
Component Missing 16 16
Fracture 14 14
Burst Container or Vessel 11 11
Difficult to Remove 11 11
Fitting Problem 11 11
Entrapment of Device 10 10
Component Misassembled 10 10
Product Quality Problem 10 10
Leak/Splash 10 10
Crack 9 9
Pressure Problem 9 9
Incorrect Measurement 9 9
Decrease in Suction 8 8
Therapeutic or Diagnostic Output Failure 7 7
Tear, Rip or Hole in Device Packaging 7 7
Material Separation 7 7
Contamination /Decontamination Problem 6 6
Material Rupture 6 6
Physical Resistance/Sticking 5 5
Unsealed Device Packaging 5 5
Partial Blockage 5 5
Device Damaged Prior to Use 4 4
No Apparent Adverse Event 4 4
Defective Device 4 4
Device Contaminated During Manufacture or Shipping 4 4
Difficult to Insert 4 4
Restricted Flow rate 3 3
Output Problem 3 3
Insufficient Information 3 3
Material Twisted/Bent 3 3
Deformation Due to Compressive Stress 2 2
Difficult to Open or Close 2 2
Failure to Infuse 2 2
Delivered as Unsterile Product 2 2
Misassembled 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Obstruction of Flow 2 2
Use of Device Problem 2 2
Inadequate Instructions for Healthcare Professional 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 452 452
No Consequences Or Impact To Patient 166 166
No Known Impact Or Consequence To Patient 80 80
Foreign Body In Patient 63 63
Insufficient Information 31 31
No Patient Involvement 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Exposure to Body Fluids 14 14
Unspecified Infection 11 11
Device Embedded In Tissue or Plaque 10 10
Hematoma 9 9
Post Operative Wound Infection 8 8
Patient Problem/Medical Problem 5 5
No Code Available 3 3
Injury 3 3
Pain 3 3
Irritation 2 2
Laceration(s) 2 2
Abscess 2 2
Unspecified Tissue Injury 2 2
Bruise/Contusion 2 2
Impaired Healing 1 1
Wound Dehiscence 1 1
Hypersensitivity/Allergic reaction 1 1
Pneumothorax 1 1
Failure of Implant 1 1
Skin Irritation 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Inflammation 1 1
Anemia 1 1
Purulent Discharge 1 1
Blood Loss 1 1
Cellulitis 1 1
Seroma 1 1
Discomfort 1 1
Fluid Discharge 1 1
Joint Laxity 1 1
Hemorrhage/Bleeding 1 1

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