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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 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 20 20
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
Crack 7 7
Defective Component 7 7
Material Split, Cut or Torn 7 7
Deformation Due to Compressive Stress 7 7
Incorrect Measurement 6 6
Suction Problem 6 6
Material Puncture/Hole 6 6
Misassembled 5 5
Material Too Soft/Flexible 5 5
Material Fragmentation 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Component Misassembled 3 3
Suction Failure 3 3
Fracture 3 3
Material Twisted/Bent 3 3
Unclear Information 3 3
Material Too Rigid or Stiff 3 3
Flushing Problem 3 3
Nonstandard Device 3 3
Device Markings/Labelling Problem 3 3
Positioning Problem 2 2
Biocompatibility 2 2
Detachment of Device or Device Component 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Contamination with Chemical or Other Material 2 2
Physical Resistance/Sticking 2 2
Failure to Capture 2 2
Material Integrity Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Material Frayed 1 1
No Flow 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Increase in Suction 1 1
Difficult to Flush 1 1
Obstruction of Flow 1 1
Peeled/Delaminated 1 1
Poor Quality Image 1 1
Fitting Problem 1 1
Complete Blockage 1 1
Inaccurate Information 1 1
Patient Device Interaction Problem 1 1
Separation Failure 1 1
Blocked Connection 1 1
Material Perforation 1 1
Malposition of Device 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 86 86
No Known Impact Or Consequence To Patient 46 46
No Consequences Or Impact To Patient 44 44
Insufficient Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Foreign Body In Patient 4 4
Vomiting 3 3
Discomfort 3 3
Aspiration/Inhalation 3 3
Hemorrhage/Bleeding 3 3
Pain 3 3
Perforation 3 3
Nausea 2 2
Perforation of Esophagus 2 2
Hematoma 2 2
No Information 2 2
No Code Available 1 1
Epistaxis 1 1
Gastrointestinal Regurgitation 1 1
Unspecified Gastrointestinal Problem 1 1
Swelling/ Edema 1 1
Pressure Sores 1 1
Needle Stick/Puncture 1 1
No Patient Involvement 1 1
Exposure to Body Fluids 1 1
Feeding Problem 1 1
Pneumothorax 1 1
Septic Shock 1 1

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