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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
Regulation Description Gastrointestinal tube and accessories.
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 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Leak/Splash 17 17
Fluid Leak 13 13
Difficult to Insert 11 11
Suction Problem 9 9
Material Deformation 9 9
Deformation Due to Compressive Stress 7 7
Material Puncture/Hole 7 7
Crack 7 7
Misassembled 5 5
Partial Blockage 4 4
Incorrect Measurement 4 4
Fracture 4 4
Material Split, Cut or Torn 4 4
Material Too Soft/Flexible 3 3
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 3 3
Detachment Of Device Component 3 3
Material Too Rigid or Stiff 3 3
Material Separation 3 3
Inadequacy of Device Shape and/or Size 2 2
Biocompatibility 2 2
Difficult to Remove 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
Device Operates Differently Than Expected 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Material Integrity Problem 1 1
No Flow 1 1
Loose or Intermittent Connection 1 1
Material Frayed 1 1
Complete Blockage 1 1
Entrapment of Device 1 1
Difficult to Flush 1 1
Material Rupture 1 1
Poor Quality Image 1 1
Nonstandard Device 1 1
Occlusion Within Device 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

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 21 21
No Information 3 3
No Code Available 3 3
Hemorrhage/Bleeding 3 3
Pain 3 3
Nausea 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Vomiting 2 2
Abdominal Distention 2 2
No Patient Involvement 2 2
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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