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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
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
DISCCATH LLC
  SUBSTANTIALLY EQUIVALENT 1
DR. JAPAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL MEDIKIT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MYCO MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 86 86
2020 77 77
2021 52 52
2022 83 83
2023 75 75
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Break 130 130
Leak/Splash 57 57
Device Markings/Labelling Problem 21 21
Detachment of Device or Device Component 17 17
Loss of or Failure to Bond 16 16
Defective Component 14 14
Device Contamination with Chemical or Other Material 14 14
Packaging Problem 12 12
Fracture 12 12
Complete Blockage 9 9
Material Separation 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Material Integrity Problem 7 7
Material Twisted/Bent 6 6
Defective Device 6 6
Fluid/Blood Leak 5 5
Material Deformation 5 5
Connection Problem 5 5
Component Misassembled 4 4
No Flow 4 4
Material Fragmentation 4 4
Device Handling Problem 4 4
Crack 4 4
Nonstandard Device 4 4
Disconnection 4 4
Insufficient Flow or Under Infusion 4 4
Entrapment of Device 3 3
Mechanical Problem 3 3
Patient Device Interaction Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Contamination /Decontamination Problem 3 3
Lack of Effect 2 2
Failure to Deliver 2 2
Appropriate Term/Code Not Available 2 2
Difficult to Remove 2 2
Patient-Device Incompatibility 2 2
Infusion or Flow Problem 2 2
Contamination 2 2
Off-Label Use 2 2
Air/Gas in Device 2 2
Unexpected Color 2 2
Physical Resistance/Sticking 2 2
Partial Blockage 2 2
Difficult to Open or Remove Packaging Material 2 2
Improper Flow or Infusion 2 2
Output Problem 2 2
Loose or Intermittent Connection 2 2
Dull, Blunt 1 1
Failure to Disconnect 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Microbial Contamination of Device 1 1
Insufficient Information 1 1
Separation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Protrusion/Extrusion 1 1
Incomplete or Missing Packaging 1 1
Component Incompatible 1 1
Device Damaged by Another Device 1 1
Misconnection 1 1
Material Discolored 1 1
Unexpected Therapeutic Results 1 1
Device Appears to Trigger Rejection 1 1
Tear, Rip or Hole in Device Packaging 1 1
Product Quality Problem 1 1
Material Split, Cut or Torn 1 1
Structural Problem 1 1
Obstruction of Flow 1 1
Delivered as Unsterile Product 1 1
Backflow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 167 167
No Known Impact Or Consequence To Patient 59 59
Foreign Body In Patient 54 54
No Consequences Or Impact To Patient 30 30
No Patient Involvement 20 20
Insufficient Information 17 17
Device Embedded In Tissue or Plaque 16 16
No Information 7 7
Pain 5 5
Needle Stick/Puncture 4 4
Inadequate Pain Relief 3 3
Headache 3 3
No Code Available 3 3
Patient Problem/Medical Problem 2 2
Blood Loss 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Discomfort 2 2
Injury 2 2
Tissue Damage 2 2
Exposure to Body Fluids 2 2
Cerebrospinal Fluid Leakage 2 2
Death 2 2
Cardiac Arrest 1 1
Tingling 1 1
Chills 1 1
Numbness 1 1
Cognitive Changes 1 1
Abscess 1 1
Spinal Arachnoiditis 1 1
Paresthesia 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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