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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

MDR Year MDR Reports MDR Events
2019 36 36
2020 23 23
2021 27 27
2022 40 40
2023 33 33
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Fluid/Blood Leak 16 16
Leak/Splash 14 14
Off-Label Use 14 14
Difficult to Insert 11 11
Insufficient Information 10 10
Material Deformation 10 10
Difficult to Remove 9 9
Partial Blockage 8 8
Deformation Due to Compressive Stress 7 7
Material Split, Cut or Torn 7 7
Crack 7 7
Defective Component 7 7
Suction Problem 6 6
Material Puncture/Hole 6 6
Incorrect Measurement 6 6
Material Too Soft/Flexible 5 5
Misassembled 5 5
Material Fragmentation 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Nonstandard Device 3 3
Device Markings/Labelling Problem 3 3
Suction Failure 3 3
Flushing Problem 3 3
Fracture 3 3
Component Misassembled 3 3
Unclear Information 3 3
Material Too Rigid or Stiff 3 3
Material Twisted/Bent 3 3
Biocompatibility 2 2
Inaccurate Information 2 2
Device Contamination with Chemical or Other Material 2 2
Detachment of Device or Device Component 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Capture 2 2
Positioning Problem 2 2
Physical Resistance/Sticking 2 2
Blocked Connection 1 1
Material Perforation 1 1
Obstruction of Flow 1 1
Patient Device Interaction Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
No Apparent Adverse Event 1 1
Separation Failure 1 1
Difficult to Flush 1 1
Complete Blockage 1 1
Peeled/Delaminated 1 1
Poor Quality Image 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 90 90
No Known Impact Or Consequence To Patient 46 46
No Consequences Or Impact To Patient 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Insufficient Information 7 7
Foreign Body In Patient 4 4
Aspiration/Inhalation 3 3
Perforation 3 3
Vomiting 3 3
Discomfort 3 3
Pain 3 3
Hemorrhage/Bleeding 3 3
Nausea 2 2
Perforation of Esophagus 2 2
No Information 2 2
Hematoma 2 2
Pneumothorax 1 1
No Code Available 1 1
Unspecified Gastrointestinal Problem 1 1
Epistaxis 1 1
Needle Stick/Puncture 1 1
Exposure to Body Fluids 1 1
Septic Shock 1 1
No Patient Involvement 1 1
Gastrointestinal Regurgitation 1 1
Swelling/ Edema 1 1
Feeding Problem 1 1
Pressure Sores 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Jan-25-2024
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