Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
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
  1.  K082772  STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP191 ...
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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Break 218 218
Leak/Splash 77 77
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 14 14
Patient-Device Incompatibility 13 13
Insufficient Information 13 13
Difficult to Remove 12 12
Material Fragmentation 11 11
Mechanical Jam 10 10
Material Separation 10 10
Inadequacy of Device Shape and/or Size 10 10
Failure To Adhere Or Bond 10 10
Material Integrity Problem 10 10
Improper or Incorrect Procedure or Method 9 9
Complete Blockage 9 9
Device Issue 9 9
Device Misassembled During Manufacturing /Shipping 8 8
Fitting Problem 8 8
Incorrect Device Or Component Shipped 8 8
Defective Device 8 8
Connection Problem 8 8
Material Twisted/Bent 7 7
Entrapment of Device 7 7
Material Deformation 7 7
Disconnection 5 5
Insufficient Flow or Under Infusion 5 5
Loose or Intermittent Connection 5 5
Physical Resistance 4 4
Occlusion Within Device 4 4
Component Misassembled 4 4
Contamination /Decontamination Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Component Missing 3 3
Appropriate Term/Code Not Available 3 3
Infusion or Flow Problem 3 3
Contamination 3 3
Difficult to Insert 3 3
Mechanical Problem 3 3
Flushing Problem 3 3
Improper Flow or Infusion 3 3
Output Problem 3 3
Sticking 3 3
Device Packaging Compromised 3 3
Patient Device Interaction Problem 3 3
Human Factors Issue 3 3
Off-Label Use 2 2
Physical Resistance/Sticking 2 2
Device-Device Incompatibility 2 2
Air/Gas in Device 2 2
Unexpected Color 2 2
Difficult to Open or Remove Packaging Material 2 2
Dull, Blunt 2 2
Component Falling 2 2
Material Rupture 2 2
Device Disinfection Or Sterilization Issue 2 2
Failure to Advance 2 2
Failure to Prime 2 2
Physical Property Issue 2 2
Failure to Deliver 2 2
Structural Problem 2 2
Device Dislodged or Dislocated 2 2
Incorrect Measurement 2 2
Material Split, Cut or Torn 2 2
Lack of Effect 2 2
Delivered as Unsterile Product 1 1
Backflow 1 1
No Apparent Adverse Event 1 1
Obstruction of Flow 1 1
Material Puncture/Hole 1 1
Retraction Problem 1 1
Migration or Expulsion of Device 1 1
Inflation Problem 1 1
Unexpected Therapeutic Results 1 1
Material Discolored 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Body Fluid 1 1
Misconnection 1 1
Device Appears to Trigger Rejection 1 1
Compatibility Problem 1 1
Corroded 1 1
Failure to Disconnect 1 1
Difficult to Advance 1 1
Malposition of Device 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 165 165
No Consequences Or Impact To Patient 101 101
Foreign Body In Patient 77 77
Device Embedded In Tissue or Plaque 54 54
No Patient Involvement 54 54
No Information 47 47
Awareness during Anaesthesia 33 33
Inadequate Pain Relief 24 24
Pain 21 21
No Code Available 17 17
Insufficient Information 16 16
Bradycardia 10 10
Cardiac Arrest 10 10
Low Blood Pressure/ Hypotension 7 7
Headache 5 5
Cerebrospinal Fluid Leakage 5 5
Needle Stick/Puncture 5 5
Tissue Damage 4 4
Hemorrhage/Bleeding 4 4
Injury 3 3
Numbness 3 3
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
Spinal Arachnoiditis 1 1
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
-
-