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TPLC
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show TPLC since
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2024
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Device
catheter, cholangiography
Product Code
GBZ
Regulation Number
878.4200
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
12
12
2020
11
11
2021
7
7
2022
7
7
2023
5
5
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
7
7
Detachment of Device or Device Component
4
4
Flushing Problem
3
3
Fluid/Blood Leak
3
3
Entrapment of Device
3
3
Device Contaminated During Manufacture or Shipping
3
3
Material Split, Cut or Torn
3
3
Obstruction of Flow
3
3
Component Missing
2
2
Delivered as Unsterile Product
2
2
Burst Container or Vessel
2
2
Material Separation
2
2
Difficult to Insert
2
2
Insufficient Information
2
2
Defective Device
2
2
Erratic or Intermittent Display
1
1
Positioning Problem
1
1
Disconnection
1
1
Misassembly by Users
1
1
Unsealed Device Packaging
1
1
Physical Resistance/Sticking
1
1
Material Deformation
1
1
Difficult to Remove
1
1
Fracture
1
1
Product Quality Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Material Puncture/Hole
1
1
Loss of or Failure to Bond
1
1
Therapeutic or Diagnostic Output Failure
1
1
No Display/Image
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
13
13
No Clinical Signs, Symptoms or Conditions
10
10
Insufficient Information
6
6
Pneumothorax
4
4
No Consequences Or Impact To Patient
3
3
Foreign Body In Patient
3
3
No Information
2
2
No Patient Involvement
2
2
Device Embedded In Tissue or Plaque
1
1
Low Blood Pressure/ Hypotension
1
1
Inflammation
1
1
Perforation
1
1
Pleural Effusion
1
1
No Code Available
1
1
Pancreatitis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Dec-02-2023
2
Atrium Medical Corporation
II
Jun-28-2022
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