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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, subclavian
Product CodeLFJ
Regulation Number 876.5540
Device Class 2

MDR Year MDR Reports MDR Events
2017 31 31
2018 31 31
2019 45 45
2020 43 43
2021 37 37
2022 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 36 36
Break 23 23
Fluid Leak 16 16
Material Frayed 16 16
Unraveled Material 16 16
Deformation Due to Compressive Stress 12 12
Difficult to Insert 12 12
Leak/Splash 11 11
Physical Resistance/Sticking 10 10
Component Incompatible 7 7
Entrapment of Device 6 6
Fracture 5 5
Defective Component 5 5
Difficult to Remove 5 5
Material Separation 5 5
Gas Leak 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Material Integrity Problem 4 4
Material Puncture/Hole 4 4
Crack 4 4
Occlusion Within Device 3 3
Obstruction of Flow 3 3
Failure to Advance 2 2
Insufficient Information 2 2
Device Damaged Prior to Use 2 2
Kinked 2 2
Material Fragmentation 2 2
Air Leak 2 2
Product Quality Problem 2 2
Failure to Infuse 2 2
Suction Problem 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 1 1
Difficult to Advance 1 1
Device Contamination with Chemical or Other Material 1 1
Fitting Problem 1 1
Dull, Blunt 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Rupture 1 1
Sticking 1 1
Stretched 1 1
Device Inoperable 1 1
Bent 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
Failure to Discharge 1 1
Material Discolored 1 1
Disconnection 1 1
Hole In Material 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Material Twisted/Bent 1 1
Suction Failure 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Aspiration Issue 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 82 82
No Clinical Signs, Symptoms or Conditions 50 50
No Known Impact Or Consequence To Patient 39 39
No Patient Involvement 6 6
Death 4 4
Air Embolism 3 3
Unspecified Infection 3 3
Foreign Body In Patient 3 3
No Information 3 3
Insufficient Information 3 3
No Code Available 2 2
Pain 2 2
Low Oxygen Saturation 2 2
Chest Pain 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Unintended Radiation Exposure 1 1
Vessel Or Plaque, Device Embedded In 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medical Components, Inc dba MedComp II Aug-08-2019
2 Medical Components, Inc dba MedComp II Apr-16-2019
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