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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
AERIN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ANCORA MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
B.BRAUN MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKSON & CO.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
LAURIMED LLC
  SUBSTANTIALLY EQUIVALENT 2
LCCS PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LIFE-TECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE, INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MYCO MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 6
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
REMINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 4
SOLO-DEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRA MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
SPECTRA MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ULTRASONIX MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNISIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 40 40
2015 38 38
2016 152 152
2017 34 34
2018 69 69
2019 86 86
2020 77 77
2021 52 52
2022 83 83
2023 75 75
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 216 216
Leak/Splash 75 75
Fracture 48 48
Fluid/Blood Leak 43 43
Nonstandard Device 41 41
No Flow 40 40
Product Quality Problem 39 39
Manufacturing, Packaging or Shipping Problem 37 37
Device Markings/Labelling Problem 28 28
Partial Blockage 28 28
Crack 26 26
Device Operates Differently Than Expected 25 25
Device Handling Problem 24 24
Detachment of Device or Device Component 20 20
Detachment Of Device Component 18 18
Loss of or Failure to Bond 17 17
Packaging Problem 16 16
Device Contamination with Chemical or Other Material 15 15
Adverse Event Without Identified Device or Use Problem 14 14
Bent 14 14
Defective Component 13 13
Patient-Device Incompatibility 13 13
Insufficient Information 13 13
Difficult to Remove 12 12
Inadequacy of Device Shape and/or Size 10 10
Failure To Adhere Or Bond 10 10
Material Fragmentation 10 10
Material Integrity Problem 10 10
Mechanical Jam 10 10
Complete Blockage 9 9
Improper or Incorrect Procedure or Method 9 9
Material Separation 9 9
Device Issue 9 9
Connection Problem 8 8
Fitting Problem 8 8
Defective Device 8 8
Incorrect Device Or Component Shipped 8 8
Device Misassembled During Manufacturing /Shipping 8 8
Material Deformation 7 7
Material Twisted/Bent 6 6
Entrapment of Device 6 6
Disconnection 5 5
Loose or Intermittent Connection 5 5
Insufficient Flow or Under Infusion 5 5
Physical Resistance 4 4
Occlusion Within Device 4 4
Component Misassembled 4 4
Appropriate Term/Code Not Available 3 3
Patient Device Interaction Problem 3 3
Infusion or Flow Problem 3 3
Output Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Contamination /Decontamination Problem 3 3
Human Factors Issue 3 3
Improper Flow or Infusion 3 3
Device Packaging Compromised 3 3
Mechanical Problem 3 3
Flushing Problem 3 3
Difficult to Insert 3 3
Contamination 3 3
Sticking 3 3
Component Missing 3 3
Material Rupture 2 2
Failure to Deliver 2 2
Dull, Blunt 2 2
Structural Problem 2 2
Failure to Advance 2 2
Component Falling 2 2
Incorrect Measurement 2 2
Failure to Prime 2 2
Off-Label Use 2 2
Device-Device Incompatibility 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Dislodged or Dislocated 2 2
Device Disinfection Or Sterilization Issue 2 2
Physical Property Issue 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
Separation Problem 1 1
Pumping Problem 1 1
Torn Material 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Material Protrusion/Extrusion 1 1
Device Contamination With Biological Material 1 1
Device Damaged by Another Device 1 1
Difficult to Advance 1 1
Compatibility Problem 1 1
Material Puncture/Hole 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Labelling, Instructions for Use or Training Problem 1 1
Hole In Material 1 1
Inflation Problem 1 1
Excess Flow or Over-Infusion 1 1
Component Incompatible 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 198 198
No Clinical Signs, Symptoms or Conditions 161 161
No Consequences Or Impact To Patient 101 101
Foreign Body In Patient 76 76
No Patient Involvement 54 54
Device Embedded In Tissue or Plaque 53 53
No Information 47 47
Awareness during Anaesthesia 33 33
Inadequate Pain Relief 24 24
Pain 20 20
No Code Available 17 17
Insufficient Information 15 15
Bradycardia 10 10
Cardiac Arrest 10 10
Low Blood Pressure/ Hypotension 7 7
Headache 5 5
Cerebrospinal Fluid Leakage 5 5
Tissue Damage 4 4
Needle Stick/Puncture 4 4
Hemorrhage/Bleeding 3 3
Injury 3 3
Numbness 2 2
Discomfort 2 2
Death 2 2
Hematoma 2 2
Cardiopulmonary Arrest 2 2
Exposure to Body Fluids 2 2
Abscess 2 2
Blood Loss 2 2
Patient Problem/Medical Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Paresthesia 1 1
Not Applicable 1 1
Underdose 1 1
Cognitive Changes 1 1
Vessel Or Plaque, Device Embedded In 1 1
Cellulitis 1 1
Incompetent Cervix 1 1
Edema 1 1
Fall 1 1
Complaint, Ill-Defined 1 1
Toxicity 1 1
Anxiety 1 1
Fungal Infection 1 1
Weakness 1 1
Tingling 1 1
Chills 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Therapeutic Effects, Unexpected 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-14-2020
2 B. Braun Medical, Inc. II May-28-2014
3 Epimed International, Inc. II Oct-31-2016
4 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Jul-09-2015
5 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Apr-29-2015
6 Pajunk GmbH II Oct-29-2019
7 RM Temena GmbH II May-12-2014
8 Smiths Medical ASD Inc. II Oct-19-2021
9 TELEFLEX MEDICAL INC II May-26-2020
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