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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, double lumen for intestinal decompression and/or intubation
Product CodeFEG
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 4 4
2017 13 13
2018 15 15
2019 36 36
2020 23 23
2021 27 27
2022 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Break 28 28
Leak/Splash 17 17
Fluid Leak 15 15
Difficult to Insert 11 11
Suction Problem 10 10
Material Deformation 9 9
Deformation Due to Compressive Stress 7 7
Material Puncture/Hole 7 7
Crack 7 7
Misassembled 5 5
Material Too Soft/Flexible 5 5
Material Split, Cut or Torn 4 4
Partial Blockage 4 4
Incorrect Measurement 4 4
Fracture 4 4
Detachment Of Device Component 3 3
Difficult to Remove 3 3
Material Too Rigid or Stiff 3 3
Material Separation 3 3
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 3 3
Device Operates Differently Than Expected 2 2
Material Twisted/Bent 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 2 2
Component Misassembled 2 2
Inadequacy of Device Shape and/or Size 2 2
Biocompatibility 2 2
Nonstandard Device 2 2
Failure to Capture 2 2
Material Fragmentation 2 2
Flushing Problem 2 2
Hole In Material 2 2
Migration or Expulsion of Device 2 2
Loose or Intermittent Connection 1 1
Material Frayed 1 1
Complete Blockage 1 1
Entrapment of Device 1 1
Difficult to Flush 1 1
Occlusion Within Device 1 1
Poor Quality Image 1 1
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Split 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Physical Resistance/Sticking 1 1
Unclear Information 1 1
No Flow 1 1
Material Integrity Problem 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 69 69
No Consequences Or Impact To Patient 52 52
No Clinical Signs, Symptoms or Conditions 33 33
Pain 5 5
Hemorrhage/Bleeding 3 3
Nausea 3 3
No Information 3 3
No Code Available 3 3
Vomiting 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abdominal Distention 2 2
No Patient Involvement 2 2
Foreign Body In Patient 2 2
Unspecified Gastrointestinal Problem 1 1
Insufficient Information 1 1
Pressure Sores 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Dyspnea 1 1
Feeding Problem 1 1
Perforation 1 1
Pleural Effusion 1 1
Swelling 1 1

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