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TPLC
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show TPLC since
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Device
catheter, peritoneal
Product Code
GBW
Regulation Number
878.4200
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
1
1
2020
3
3
2021
8
8
2022
6
6
2023
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
15
15
Adverse Event Without Identified Device or Use Problem
5
5
Break
4
4
Partial Blockage
3
3
Material Split, Cut or Torn
2
2
Material Separation
2
2
Disconnection
1
1
Material Frayed
1
1
Fitting Problem
1
1
Activation, Positioning or Separation Problem
1
1
Burst Container or Vessel
1
1
Physical Resistance/Sticking
1
1
Crack
1
1
Device Damaged Prior to Use
1
1
Material Disintegration
1
1
Material Puncture/Hole
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Contamination
1
1
Patient Device Interaction Problem
1
1
Obstruction of Flow
1
1
Material Twisted/Bent
1
1
Material Rupture
1
1
Material Deformation
1
1
Packaging Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Detachment of Device or Device Component
1
1
Material Protrusion/Extrusion
1
1
Failure to Advance
1
1
Appropriate Term/Code Not Available
1
1
Naturally Worn
1
1
Self-Activation or Keying
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Peritonitis
17
17
No Clinical Signs, Symptoms or Conditions
10
10
Unspecified Infection
9
9
No Code Available
5
5
Abdominal Pain
3
3
Death
3
3
Foreign Body In Patient
3
3
Pain
3
3
Hemorrhage/Bleeding
3
3
Sepsis
2
2
No Consequences Or Impact To Patient
2
2
High Blood Pressure/ Hypertension
1
1
Perforation
1
1
Blood Loss
1
1
Injury
1
1
Fever
1
1
Insufficient Information
1
1
Tachycardia
1
1
Myocardial Infarction
1
1
Low Blood Pressure/ Hypotension
1
1
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