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TPLC
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show TPLC since
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Device
catheter, continuous irrigation
Regulation Description
Introduction/drainage catheter and accessories.
Product Code
GBQ
Regulation Number
878.4200
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
9
9
2021
1
1
2022
7
7
2023
32
32
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
20
20
Break
13
13
Physical Resistance/Sticking
6
6
Therapeutic or Diagnostic Output Failure
5
5
Gas/Air Leak
3
3
Leak/Splash
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Material Twisted/Bent
2
2
Detachment of Device or Device Component
2
2
Air/Gas in Device
2
2
Material Rupture
1
1
Separation Failure
1
1
Failure to Cut
1
1
Failure to Advance
1
1
Lack of Effect
1
1
Difficult to Remove
1
1
Entrapment of Device
1
1
Unsealed Device Packaging
1
1
Explosion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
24
24
No Clinical Signs, Symptoms or Conditions
21
21
No Known Impact Or Consequence To Patient
5
5
Hemorrhage/Bleeding
2
2
Pain
2
2
Failure of Implant
2
2
Pneumothorax
2
2
No Code Available
1
1
Device Embedded In Tissue or Plaque
1
1
Obstruction/Occlusion
1
1
Unspecified Infection
1
1
Foreign Body In Patient
1
1
Unspecified Kidney or Urinary Problem
1
1
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