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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
  1.  K173110  GRAFTSITE
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
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 129 129
Leak/Splash 46 46
Fracture 27 27
Device Markings/Labelling Problem 19 19
Detachment of Device or Device Component 16 16
Loss of or Failure to Bond 16 16
Fluid/Blood Leak 13 13
Device Contamination with Chemical or Other Material 13 13
Packaging Problem 10 10
Defective Component 9 9
Complete Blockage 9 9
Failure To Adhere Or Bond 8 8
Material Separation 7 7
Entrapment of Device 6 6
Nonstandard Device 6 6
Crack 6 6
Material Integrity Problem 6 6
Defective Device 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Material Deformation 5 5
Material Twisted/Bent 5 5
No Flow 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Patient-Device Incompatibility 4 4
Contamination /Decontamination Problem 3 3
Connection Problem 3 3
Insufficient Flow or Under Infusion 3 3
Therapeutic or Diagnostic Output Failure 3 3
Mechanical Problem 3 3
Difficult to Remove 3 3
Device Handling Problem 3 3
Component Misassembled 3 3
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Off-Label Use 2 2
Product Quality Problem 2 2
Loose or Intermittent Connection 2 2
Incorrect Measurement 2 2
Disconnection 2 2
Material Fragmentation 2 2
Detachment Of Device Component 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Deliver 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Difficult to Advance 1 1
Contamination of Device Ingredient or Reagent 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Failure to Advance 1 1
Physical Resistance 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Device Dislodged or Dislocated 1 1
Device Or Device Fragments Location Unknown 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Material Protrusion/Extrusion 1 1
Component Incompatible 1 1
Bent 1 1
Backflow 1 1
Partial Blockage 1 1
Hole In Material 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Discolored 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Separation Problem 1 1
Air/Gas in Device 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 108 108
No Known Impact Or Consequence To Patient 97 97
Foreign Body In Patient 57 57
No Consequences Or Impact To Patient 43 43
Device Embedded In Tissue or Plaque 24 24
No Patient Involvement 24 24
No Information 13 13
Insufficient Information 8 8
No Code Available 7 7
Pain 6 6
Inadequate Pain Relief 4 4
Discomfort 2 2
Injury 2 2
Needle Stick/Puncture 2 2
Blood Loss 2 2
Tissue Damage 2 2
Exposure to Body Fluids 2 2
Death 2 2
Hematoma 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Patient Problem/Medical Problem 2 2
Hemorrhage/Bleeding 1 1
Cardiac Arrest 1 1
Cerebrospinal Fluid Leakage 1 1
Tingling 1 1
Chills 1 1
Abscess 1 1
Underdose 1 1
Numbness 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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