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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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 161 165
Disconnection 127 127
Dull, Blunt 99 99
Suction Problem 89 89
Suction Failure 84 84
Inflation Problem 68 68
Detachment of Device or Device Component 53 53
Material Fragmentation 50 50
Device Contamination with Chemical or Other Material 45 48
Fluid/Blood Leak 38 38
Burst Container or Vessel 28 28
Fracture 18 18
Component Missing 17 17
Difficult to Remove 15 15
Leak/Splash 15 15
Material Rupture 14 14
Fitting Problem 14 14
Crack 13 13
Material Split, Cut or Torn 13 13
Pressure Problem 12 12
Therapeutic or Diagnostic Output Failure 11 11
Improper or Incorrect Procedure or Method 10 10
Contamination /Decontamination Problem 10 10
Device Damaged Prior to Use 9 9
Entrapment of Device 9 9
Detachment Of Device Component 9 9
Incorrect Measurement 9 9
Physical Resistance/Sticking 9 9
Material Separation 8 8
Device Operates Differently Than Expected 8 8
Partial Blockage 7 7
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
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
Torn Material 2 2
Noise, Audible 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Infusion or Flow Problem 2 2
Device Markings/Labelling Problem 2 2
Connection Problem 2 2
Defective Device 2 2
Structural Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Infuse 2 2
Unsealed Device Packaging 2 2
Nonstandard Device 2 2
Inadequate Instructions for Healthcare Professional 2 2
Contamination 2 2
Decrease in Suction 2 2
Unintended Ejection 1 1
Inaccurate Flow Rate 1 1
Component Falling 1 1
Material Frayed 1 1
Hole In Material 1 1
Migration or Expulsion of Device 1 1
No Device Output 1 1
Product Quality Problem 1 1
Out-Of-Box Failure 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
Blocked Connection 1 1
Cut In Material 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination With Biological Material 1 1
Device Packaging Compromised 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Device Dislodged or Dislocated 1 1
Incorrect Device Or Component Shipped 1 1
No Pressure 1 1
Medical Gas Supply Problem 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 347 347
No Known Impact Or Consequence To Patient 313 313
No Clinical Signs, Symptoms or Conditions 312 312
No Patient Involvement 112 115
Foreign Body In Patient 89 89
Insufficient Information 27 27
Device Embedded In Tissue or Plaque 24 24
No Information 21 25
No Code Available 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Patient Problem/Medical Problem 11 11
Hematoma 8 8
Unspecified Infection 6 6
Pain 6 6
Injury 3 3
Skin Irritation 2 2
Impaired Healing 2 2
Irritation 2 2
Bruise/Contusion 2 2
Fever 2 2
Tissue Damage 2 2
Test Result 1 1
Foreign Body Sensation in Eye 1 1
Edema 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abdominal Pain 1 1
Abscess 1 1
Exposure to Body Fluids 1 1
Laceration(s) 1 1
Necrosis 1 1
Hemorrhage/Bleeding 1 1
Hemorrhage, Subdural 1 1
Failure of Implant 1 1
Blood Loss 1 1
Joint Laxity 1 1
Swelling 1 1
Sepsis 1 1
Fasciitis 1 1
Discomfort 1 1

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