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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
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 1 1
2016 4 4
2017 13 13
2018 15 15
2019 36 36
2020 23 23
2021 27 27
2022 40 40
2023 33 33
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Break 32 32
Fluid/Blood Leak 19 19
Leak/Splash 17 17
Off-Label Use 15 15
Difficult to Insert 11 11
Suction Problem 11 11
Insufficient Information 11 11
Material Deformation 10 10
Partial Blockage 9 9
Difficult to Remove 9 9
Crack 8 8
Defective Component 7 7
Material Puncture/Hole 7 7
Incorrect Measurement 7 7
Deformation Due to Compressive Stress 7 7
Material Split, Cut or Torn 7 7
Material Too Soft/Flexible 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Misassembled 5 5
Fracture 4 4
Material Fragmentation 4 4
Improper or Incorrect Procedure or Method 4 4
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 3 3
Component Misassembled 3 3
Material Twisted/Bent 3 3
Suction Failure 3 3
Unclear Information 3 3
Flushing Problem 3 3
Hole In Material 3 3
Detachment Of Device Component 3 3
Nonstandard Device 3 3
Material Too Rigid or Stiff 3 3
Material Separation 3 3
Inadequacy of Device Shape and/or Size 2 2
Migration or Expulsion of Device 2 2
Failure to Capture 2 2
Physical Resistance/Sticking 2 2
Device Operates Differently Than Expected 2 2
Biocompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Material Integrity Problem 1 1
Blocked Connection 1 1
Fitting Problem 1 1
Material Perforation 1 1
Difficult to Open or Close 1 1
No Flow 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Complete Blockage 1 1
Entrapment of Device 1 1
Difficult to Flush 1 1
Material Frayed 1 1
Inadequate Instructions for Healthcare Professional 1 1
Loose or Intermittent Connection 1 1
Poor Quality Image 1 1
Occlusion Within Device 1 1
Peeled/Delaminated 1 1
Increase in Suction 1 1
Material Rupture 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Failure to Advance 1 1
Split 1 1
Separation Failure 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85
No Known Impact Or Consequence To Patient 70 70
No Consequences Or Impact To Patient 53 53
Insufficient Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Foreign Body In Patient 5 5
Pain 5 5
No Information 4 4
No Code Available 3 3
Vomiting 3 3
Perforation 3 3
Discomfort 3 3
Aspiration/Inhalation 3 3
Hemorrhage/Bleeding 3 3
Nausea 3 3
Hematoma 2 2
Pressure Sores 2 2
Perforation of Esophagus 2 2
Abdominal Distention 2 2
No Patient Involvement 2 2
Needle Stick/Puncture 1 1
Epistaxis 1 1
Unspecified Gastrointestinal Problem 1 1
Swelling/ Edema 1 1
Injury 1 1
Pleural Effusion 1 1
Pneumothorax 1 1
Surgical procedure, repeated 1 1
Septic Shock 1 1
Swelling 1 1
Unspecified Infection 1 1
Exposure to Body Fluids 1 1
Dyspnea 1 1
Feeding Problem 1 1

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