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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, conduction, anesthetic (w/wo introducer)
Regulation Description Anesthesia conduction needle.
Product CodeBSP
Regulation Number 868.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
AERIN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ANCORA MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
DISCCATH LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL MEDIKIT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MYCO MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 77 77
2021 52 52
2022 84 84
2023 75 75
2024 66 66
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 114 114
Leak/Splash 50 50
Device Markings/Labelling Problem 18 18
Complete Blockage 18 18
Defective Component 14 14
Packaging Problem 11 11
Device Contamination with Chemical or Other Material 11 11
Loss of or Failure to Bond 8 8
Product Quality Problem 8 8
Detachment of Device or Device Component 8 8
Material Twisted/Bent 7 7
Nonstandard Device 7 7
Material Integrity Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Material Separation 6 6
No Flow 6 6
Contamination 6 6
Connection Problem 6 6
Fracture 5 5
Defective Device 5 5
Material Deformation 5 5
Disconnection 4 4
Material Fragmentation 4 4
Fluid/Blood Leak 4 4
Device Handling Problem 4 4
Insufficient Flow or Under Infusion 4 4
Physical Resistance/Sticking 3 3
Mechanical Problem 3 3
Patient Device Interaction Problem 3 3
Loose or Intermittent Connection 3 3
Unexpected Color 2 2
Separation Problem 2 2
Off-Label Use 2 2
Sharp Edges 2 2
Air/Gas in Device 2 2
Difficult to Open or Remove Packaging Material 2 2
Patient-Device Incompatibility 2 2
Lack of Effect 2 2
Partial Blockage 2 2
Failure to Deliver 2 2
Infusion or Flow Problem 2 2
Entrapment of Device 2 2
Improper Flow or Infusion 2 2
Tear, Rip or Hole in Device Packaging 1 1
Delivered as Unsterile Product 1 1
Difficult to Remove 1 1
Appropriate Term/Code Not Available 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure to Disconnect 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 198 198
Foreign Body In Patient 57 57
Insufficient Information 23 23
No Known Impact Or Consequence To Patient 21 21
No Patient Involvement 15 15
No Consequences Or Impact To Patient 14 14
Inadequate Pain Relief 8 8
Device Embedded In Tissue or Plaque 6 6
Pain 5 5
Needle Stick/Puncture 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Headache 3 3
No Information 2 2
Cerebrospinal Fluid Leakage 2 2
Hematoma 2 2
Nerve Damage 2 2
Death 2 2
Hemorrhage/Bleeding 2 2
Cognitive Changes 1 1
Chills 1 1
Injury 1 1
Tissue Damage 1 1
Paresthesia 1 1
Blood Loss 1 1
Abscess 1 1
Exposure to Body Fluids 1 1
Spinal Arachnoiditis 1 1
Cardiac Arrest 1 1
Numbness 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-14-2020
2 Smiths Medical ASD Inc. II Oct-19-2021
3 TELEFLEX MEDICAL INC II May-26-2020
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