• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, subclavian
Regulation Description Blood access device and accessories.
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

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 36 36
Break 22 22
Fluid Leak 16 16
Material Frayed 16 16
Unraveled Material 15 15
Difficult to Insert 12 12
Leak/Splash 10 10
Physical Resistance/Sticking 10 10
Deformation Due to Compressive Stress 8 8
Entrapment of Device 6 6
Fracture 5 5
Defective Component 5 5
Material Separation 5 5
Difficult to Remove 5 5
Material Puncture/Hole 4 4
Component Incompatible 4 4
Crack 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Material Integrity Problem 4 4
Gas Leak 4 4
Occlusion Within Device 3 3
Obstruction of Flow 3 3
Failure to Advance 2 2
Failure to Infuse 2 2
Detachment of Device or Device Component 2 2
Product Quality Problem 2 2
Suction Problem 2 2
Device Damaged Prior to Use 2 2
Kinked 2 2
Material Fragmentation 2 2
Air Leak 2 2
Insufficient Information 2 2
Material Split, Cut or Torn 1 1
Suction Failure 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Bent 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
Failure to Discharge 1 1
Disconnection 1 1
Hole In Material 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Sticking 1 1
Device Inoperable 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Rupture 1 1
Device Operates Differently Than Expected 1 1
Difficult to Advance 1 1
Device Contamination with Chemical or Other Material 1 1
Dull, Blunt 1 1
Aspiration Issue 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 40 40
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
No Code Available 2 2
Insufficient Information 2 2
Pain 2 2
Low Oxygen Saturation 2 2
Chest Pain 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Vessel Or Plaque, Device Embedded In 1 1
Unintended Radiation Exposure 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
-
-