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TPLC
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Device
tube, double lumen for intestinal decompression and/or intubation
Product Code
FEG
Regulation Number
876.5980
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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