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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
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
DISCCATH LLC
  SUBSTANTIALLY EQUIVALENT 1
DR. JAPAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENTELLUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL MEDIKIT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD)
  SUBSTANTIALLY EQUIVALENT 1
MYCO MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPECTRA MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
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
2017 34 34
2018 69 69
2019 86 86
2020 77 77
2021 53 53
2022 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Break 132 132
Leak/Splash 42 42
Fracture 28 28
Device Markings/Labelling Problem 19 19
Fluid Leak 17 17
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
Crack 11 11
Defective Component 9 9
Packaging Problem 9 9
Failure To Adhere Or Bond 8 8
Complete Blockage 7 7
Nonstandard Device 7 7
Material Separation 6 6
Entrapment of Device 6 6
Defective Device 6 6
Patient-Device Incompatibility 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Material Twisted/Bent 5 5
No Flow 5 5
Material Deformation 5 5
Material Integrity Problem 5 5
Device Operates Differently Than Expected 5 5
Difficult to Remove 5 5
Product Quality Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Material Fragmentation 4 4
Detachment Of Device Component 4 4
Device Handling Problem 4 4
Component Misassembled 3 3
Therapeutic or Diagnostic Output Failure 3 3
Bent 3 3
Improper or Incorrect Procedure or Method 3 3
Insufficient Flow or Under Infusion 3 3
Mechanical Problem 3 3
Contamination /Decontamination Problem 3 3
Connection Problem 3 3
Device Misassembled During Manufacturing /Shipping 2 2
Difficult to Open or Remove Packaging Material 2 2
Incorrect Measurement 2 2
Off-Label Use 2 2
Disconnection 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Infusion or Flow Problem 2 2
Appropriate Term/Code Not Available 2 2
Separation Problem 1 1
Air/Gas in Device 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Hole In Material 1 1
Labelling, Instructions for Use or Training Problem 1 1
Backflow 1 1
Partial Blockage 1 1
Component Falling 1 1
Component Incompatible 1 1
Material Rupture 1 1
Sticking 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Occlusion Within Device 1 1
Device Dislodged or Dislocated 1 1
Improper Flow or Infusion 1 1
Device Damaged by Another Device 1 1
Difficult to Advance 1 1
Material Protrusion/Extrusion 1 1
Output Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Or Device Fragments Location Unknown 1 1
Device Disinfection Or Sterilization Issue 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Failure to Deliver 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 105 105
No Clinical Signs, Symptoms or Conditions 88 88
Foreign Body In Patient 54 54
No Consequences Or Impact To Patient 46 46
Device Embedded In Tissue or Plaque 31 31
No Patient Involvement 24 24
No Information 16 16
Inadequate Pain Relief 11 11
Pain 10 10
Insufficient Information 8 8
No Code Available 7 7
Needle Stick/Puncture 2 2
Blood Loss 2 2
Patient Problem/Medical Problem 2 2
Tissue Damage 2 2
Injury 2 2
Abscess 2 2
Exposure to Body Fluids 2 2
Cerebrospinal Fluid Leakage 2 2
Death 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Cardiac Arrest 1 1
Cellulitis 1 1
Awareness during Anaesthesia 1 1
Vessel Or Plaque, Device Embedded In 1 1
Discomfort 1 1
Tingling 1 1
Chills 1 1
Underdose 1 1
Numbness 1 1
Fungal Infection 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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