Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 introducer, syringe needle
Regulation Description Syringe needle introducer.
Product CodeKZH
Regulation Number 880.6920
Device Class 2


Premarket Reviews
ManufacturerDecision
EMED TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNTHON HISPANIA S.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 87 91
2022 58 66
2023 35 35
2024 27 27
2025 17 17
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 55 55
Misfire 52 52
Defective Device 12 14
Mechanical Jam 9 11
Material Twisted/Bent 7 9
Physical Resistance/Sticking 7 7
Fluid/Blood Leak 5 5
Break 5 6
Therapeutic or Diagnostic Output Failure 5 5
Failure to Deliver 4 4
Ejection Problem 4 4
Patient-Device Incompatibility 3 5
Defective Component 3 3
Insufficient Flow or Under Infusion 3 4
Output Problem 3 3
Activation, Positioning or Separation Problem 2 5
Failure to Infuse 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Packaging Problem 2 2
Device Slipped 2 2
Failure to Eject 2 2
Sharp Edges 2 2
Disconnection 1 1
Complete Blockage 1 1
Loss of or Failure to Bond 1 1
Device Alarm System 1 1
Obstruction of Flow 1 1
Dull, Blunt 1 3
Use of Device Problem 1 1
Unexpected Therapeutic Results 1 1
Material Separation 1 1
Key or Button Unresponsive/not Working 1 1
Noise, Audible 1 1
Insufficient Information 1 1
Unintended Movement 1 1
Protective Measures Problem 1 1
No Flow 1 1
Mechanics Altered 1 1
Improper Flow or Infusion 1 1
Fail-Safe Problem 1 1
Device Dislodged or Dislocated 1 1
Detachment of Device or Device Component 1 1
Connection Problem 1 1
Failure to Fire 1 1
Retraction Problem 1 1
Unintended Collision 1 1
Mechanical Problem 1 1
Leak/Splash 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 151 154
Insufficient Information 40 45
No Consequences Or Impact To Patient 11 11
Needle Stick/Puncture 6 6
Hyperglycemia 4 4
Bruise/Contusion 3 3
Unspecified Infection 2 2
Hypersensitivity/Allergic reaction 2 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arthralgia 1 1
Sepsis 1 1
Inflammation 1 1
Abrasion 1 1
Fever 1 1
Chest Pain 1 1
Dyspnea 1 1
Pain 1 3
Tinnitus 1 1
Hemorrhage/Bleeding 1 1
Device Embedded In Tissue or Plaque 1 1

-
-