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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)
Product CodeBSP
Regulation Number 868.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
ANCORA MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
DISCCATH LLC
  SUBSTANTIALLY EQUIVALENT 1
DR. JAPAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL MEDIKIT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD)
  SUBSTANTIALLY EQUIVALENT 1
MYCO MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 3
SUMMIT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 69 69
2019 86 86
2020 77 77
2021 53 53
2022 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Break 128 128
Leak/Splash 44 44
Fracture 27 27
Device Markings/Labelling Problem 19 19
Loss of or Failure to Bond 16 16
Detachment of Device or Device Component 16 16
Device Contamination with Chemical or Other Material 13 13
Fluid/Blood Leak 12 12
Packaging Problem 10 10
Defective Component 9 9
Failure To Adhere Or Bond 8 8
Complete Blockage 7 7
Material Separation 7 7
Material Integrity Problem 6 6
Crack 6 6
Nonstandard Device 6 6
Defective Device 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Entrapment of Device 6 6
Material Deformation 5 5
Material Twisted/Bent 5 5
Manufacturing, Packaging or Shipping Problem 4 4
No Flow 4 4
Therapeutic or Diagnostic Output Failure 3 3
Mechanical Problem 3 3
Component Misassembled 3 3
Contamination /Decontamination Problem 3 3
Connection Problem 3 3
Insufficient Flow or Under Infusion 3 3
Device Handling Problem 3 3
Difficult to Remove 3 3
Patient-Device Incompatibility 2 2
Infusion or Flow Problem 2 2
Off-Label Use 2 2
Material Fragmentation 2 2
Physical Resistance/Sticking 2 2
Detachment Of Device Component 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Disconnection 2 2
Loose or Intermittent Connection 2 2
Improper Flow or Infusion 2 2
Difficult to Open or Remove Packaging Material 2 2
Incorrect Measurement 2 2
Material Split, Cut or Torn 2 2
Separation Problem 1 1
Output Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Or Device Fragments Location Unknown 1 1
Device Dislodged or Dislocated 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Failure to Deliver 1 1
Structural Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Backflow 1 1
Dull, Blunt 1 1
Difficult to Advance 1 1
Misconnection 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Contamination of Device Ingredient or Reagent 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Material Discolored 1 1
Partial Blockage 1 1
Air/Gas in Device 1 1
Hole In Material 1 1
Component Incompatible 1 1
Bent 1 1
Physical Resistance 1 1
Material Protrusion/Extrusion 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 101 101
No Known Impact Or Consequence To Patient 97 97
Foreign Body In Patient 56 56
No Consequences Or Impact To Patient 43 43
No Patient Involvement 24 24
Device Embedded In Tissue or Plaque 24 24
No Information 13 13
Insufficient Information 8 8
No Code Available 7 7
Pain 6 6
Inadequate Pain Relief 4 4
Patient Problem/Medical Problem 2 2
Death 2 2
Tissue Damage 2 2
Hematoma 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Exposure to Body Fluids 2 2
Injury 2 2
Needle Stick/Puncture 2 2
Blood Loss 2 2
Cardiac Arrest 1 1
Discomfort 1 1
Numbness 1 1
Underdose 1 1
Abscess 1 1
Cerebrospinal Fluid Leakage 1 1
Chills 1 1
Tingling 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-14-2020
2 Pajunk GmbH II Oct-29-2019
3 Smiths Medical ASD Inc. II Oct-19-2021
4 TELEFLEX MEDICAL INC II May-26-2020
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