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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 52 52
2022 83 83
2023 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Break 137 137
Leak/Splash 57 57
Fracture 28 28
Device Markings/Labelling Problem 23 23
Detachment of Device or Device Component 19 19
Loss of or Failure to Bond 17 17
Fluid/Blood Leak 14 14
Device Contamination with Chemical or Other Material 14 14
Defective Component 13 13
Packaging Problem 12 12
Complete Blockage 9 9
Failure To Adhere Or Bond 8 8
Material Separation 8 8
Material Integrity Problem 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Material Deformation 6 6
Material Twisted/Bent 6 6
Connection Problem 6 6
Defective Device 6 6
Entrapment of Device 6 6
Nonstandard Device 6 6
Crack 5 5
Disconnection 5 5
Device Handling Problem 5 5
Component Misassembled 4 4
Material Fragmentation 4 4
Patient-Device Incompatibility 4 4
Insufficient Flow or Under Infusion 4 4
No Flow 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Contamination /Decontamination Problem 3 3
Mechanical Problem 3 3
Difficult to Remove 3 3
Therapeutic or Diagnostic Output Failure 3 3
Output Problem 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Unexpected Color 2 2
Air/Gas in Device 2 2
Lack of Effect 2 2
Off-Label Use 2 2
Product Quality Problem 2 2
Loose or Intermittent Connection 2 2
Incorrect Measurement 2 2
Contamination 2 2
Partial Blockage 2 2
Detachment Of Device Component 2 2
Improper or Incorrect Procedure or Method 2 2
Structural Problem 2 2
Failure to Deliver 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Difficult to Open or Remove Packaging Material 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
Device Dislodged or Dislocated 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Protrusion/Extrusion 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Obstruction of Flow 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Failure to Advance 1 1
Physical Resistance 1 1
Device Or Device Fragments Location Unknown 1 1
Component Incompatible 1 1
Bent 1 1
Backflow 1 1
Material Discolored 1 1
Hole In Material 1 1
Labelling, Instructions for Use or Training Problem 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
Patient Device Interaction Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 151 151
No Known Impact Or Consequence To Patient 97 97
Foreign Body In Patient 60 60
No Consequences Or Impact To Patient 43 43
Device Embedded In Tissue or Plaque 24 24
No Patient Involvement 24 24
Insufficient Information 13 13
No Information 13 13
No Code Available 7 7
Pain 7 7
Inadequate Pain Relief 4 4
Needle Stick/Puncture 3 3
Discomfort 2 2
Injury 2 2
Exposure to Body Fluids 2 2
Tissue Damage 2 2
Death 2 2
Headache 2 2
Hematoma 2 2
Patient Problem/Medical Problem 2 2
Blood Loss 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abscess 1 1
Paresthesia 1 1
Hemorrhage/Bleeding 1 1
Tingling 1 1
Chills 1 1
Cardiac Arrest 1 1
Cerebrospinal Fluid Leakage 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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