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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, cholangiography
Product CodeGBZ
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2017 21 21
2018 51 51
2019 12 12
2020 11 11
2021 7 7
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 17 17
Unsealed Device Packaging 13 13
Material Separation 11 11
Fluid/Blood Leak 6 6
Device Contamination with Chemical or Other Material 5 5
Protective Measures Problem 4 4
Device Contaminated During Manufacture or Shipping 3 3
Positioning Problem 3 3
Material Split, Cut or Torn 3 3
Flushing Problem 3 3
Entrapment of Device 3 3
Detachment Of Device Component 3 3
Obstruction of Flow 3 3
Detachment of Device or Device Component 3 3
Structural Problem 2 2
Split 2 2
Crack 2 2
Complete Blockage 2 2
Difficult to Insert 2 2
Leak/Splash 2 2
Delivered as Unsterile Product 2 2
Component Missing 2 2
Insufficient Information 2 2
Defective Device 2 2
Material Deformation 2 2
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Folded 1 1
Gas/Air Leak 1 1
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Physical Resistance/Sticking 1 1
Occlusion Within Device 1 1
Inadequate Instructions for Healthcare Professional 1 1
Fracture 1 1
Material Fragmentation 1 1
High impedance 1 1
Loss of or Failure to Bond 1 1
Disconnection 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Separation Failure 1 1
Physical Resistance 1 1
Failure to Advance 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Device Slipped 1 1
Sticking 1 1
Unraveled Material 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Defective Component 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 54 54
No Patient Involvement 15 15
No Information 10 10
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 5 5
Pneumothorax 4 4
Insufficient Information 4 4
Foreign Body In Patient 4 4
No Code Available 3 3
Inadequate Pain Relief 2 2
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Inflammation 1 1
Pleural Effusion 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Jun-28-2022
2 Atrium Medical Corporation II Dec-06-2018
3 Atrium Medical Corporation II Feb-16-2017
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