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TPLC
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show TPLC since
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Device
tube, double lumen for intestinal decompression and/or intubation
Product Code
FEG
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
14
14
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
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
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
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
Vomiting
2
2
No Information
2
2
No Code Available
1
1
Epistaxis
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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