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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
2019 45 45
2020 43 43
2021 37 37
2022 34 34
2023 44 44
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Unraveled Material 35 35
Material Deformation 35 35
Deformation Due to Compressive Stress 29 29
Break 24 24
Material Frayed 15 15
Fluid/Blood Leak 15 15
Physical Resistance/Sticking 14 14
Material Twisted/Bent 12 12
Material Separation 10 10
Difficult to Insert 8 8
Material Puncture/Hole 7 7
Component Incompatible 7 7
Obstruction of Flow 7 7
Fracture 5 5
Defective Component 4 4
Failure to Infuse 4 4
Entrapment of Device 4 4
Product Quality Problem 4 4
Difficult to Remove 4 4
Gas/Air Leak 4 4
Material Integrity Problem 4 4
Leak/Splash 3 3
Crack 3 3
Suction Problem 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Insufficient Information 2 2
Migration 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Suction Failure 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Improper Flow or Infusion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Advance 1 1
Stretched 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Detachment of Device or Device Component 1 1
Difficult to Advance 1 1
Device Contamination with Chemical or Other Material 1 1
Positioning Failure 1 1
Failure to Discharge 1 1
Material Discolored 1 1
Loss of or Failure to Bond 1 1
Complete Blockage 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 131 131
No Consequences Or Impact To Patient 57 57
No Known Impact Or Consequence To Patient 18 18
Insufficient Information 8 8
No Patient Involvement 3 3
Intraoperative Pain 2 2
Anemia 2 2
Chest Pain 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 2 2
Myocardial Infarction 1 1
Nausea 1 1
Pain 1 1
Death 1 1
Fever 1 1
Foreign Body In Patient 1 1
No Code Available 1 1
Respiratory Insufficiency 1 1
Unintended Radiation Exposure 1 1
Vessel Or Plaque, Device Embedded In 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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