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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device needle, conduction, anesthetic (w/wo introducer)
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
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
DISCCATH LLC
  SUBSTANTIALLY EQUIVALENT 1
DR. JAPAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K183316  Dr J Spinal and Epidural Needles
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 75 75
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Break 145 145
Leak/Splash 61 61
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 14 14
Packaging Problem 12 12
Adverse Event Without Identified Device or Use Problem 9 9
Material Integrity Problem 9 9
Material Separation 9 9
Complete Blockage 9 9
Failure To Adhere Or Bond 8 8
Entrapment of Device 7 7
Material Twisted/Bent 7 7
Device Handling Problem 7 7
Material Deformation 6 6
Nonstandard Device 6 6
Connection Problem 6 6
Defective Device 6 6
Material Fragmentation 5 5
Crack 5 5
Disconnection 5 5
Insufficient Flow or Under Infusion 4 4
Patient-Device Incompatibility 4 4
Manufacturing, Packaging or Shipping Problem 4 4
No Flow 4 4
Component Misassembled 4 4
Patient Device Interaction Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Contamination /Decontamination Problem 3 3
Mechanical Problem 3 3
Difficult to Remove 3 3
Off-Label Use 2 2
Product Quality Problem 2 2
Inadequacy of Device Shape and/or Size 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
Device Misassembled During Manufacturing /Shipping 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
Structural Problem 2 2
Failure to Deliver 2 2
Appropriate Term/Code Not Available 2 2
Output Problem 2 2
Unexpected Color 2 2
Air/Gas in Device 2 2
Lack of Effect 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Separation Problem 1 1
Insufficient Information 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
Failure to Disconnect 1 1
Physical Resistance 1 1
Device Or Device Fragments Location Unknown 1 1
Device Dislodged or Dislocated 1 1
Material Protrusion/Extrusion 1 1
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
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
Sticking 1 1
Unexpected Therapeutic Results 1 1
Device Appears to Trigger Rejection 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 163 163
No Known Impact Or Consequence To Patient 97 97
Foreign Body In Patient 66 66
No Consequences Or Impact To Patient 43 43
Device Embedded In Tissue or Plaque 26 26
No Patient Involvement 24 24
Insufficient Information 16 16
No Information 13 13
Pain 8 8
No Code Available 7 7
Inadequate Pain Relief 4 4
Needle Stick/Puncture 4 4
Headache 3 3
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Discomfort 2 2
Injury 2 2
Numbness 2 2
Tissue Damage 2 2
Exposure to Body Fluids 2 2
Cerebrospinal Fluid Leakage 2 2
Death 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
Spinal Arachnoiditis 1 1
Paresthesia 1 1
Cardiac Arrest 1 1
Tingling 1 1
Chills 1 1
Underdose 1 1
Cognitive Changes 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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