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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
Material Deformation 10 10
Insufficient Information 10 10
Difficult to Remove 9 9
Partial Blockage 8 8
Crack 7 7
Defective Component 7 7
Deformation Due to Compressive Stress 7 7
Material Split, Cut or Torn 7 7
Material Puncture/Hole 6 6
Suction Problem 6 6
Incorrect Measurement 6 6
Misassembled 5 5
Material Too Soft/Flexible 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Material Fragmentation 4 4
Nonstandard Device 3 3
Flushing Problem 3 3
Fracture 3 3
Material Too Rigid or Stiff 3 3
Component Misassembled 3 3
Material Twisted/Bent 3 3
Device Markings/Labelling Problem 3 3
Suction Failure 3 3
Unclear Information 3 3
Physical Resistance/Sticking 2 2
Device Contamination with Chemical or Other Material 2 2
Positioning Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Detachment of Device or Device Component 2 2
Biocompatibility 2 2
Failure to Capture 2 2
Complete Blockage 1 1
Difficult to Flush 1 1
Peeled/Delaminated 1 1
Poor Quality Image 1 1
Material Frayed 1 1
Loose or Intermittent Connection 1 1
Blocked Connection 1 1
Obstruction of Flow 1 1
Separation Failure 1 1
Malposition of Device 1 1
Increase in Suction 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Material Perforation 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Difficult to Open or Close 1 1
No Flow 1 1
Material Integrity Problem 1 1
Inaccurate Information 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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