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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
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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 126 126
Leak/Splash 54 54
Device Markings/Labelling Problem 21 21
Detachment of Device or Device Component 17 17
Loss of or Failure to Bond 16 16
Device Contamination with Chemical or Other Material 14 14
Defective Component 13 13
Fracture 12 12
Packaging Problem 12 12
Complete Blockage 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Material Integrity Problem 7 7
Material Separation 7 7
Defective Device 6 6
Fluid/Blood Leak 5 5
Material Deformation 5 5
Connection Problem 5 5
Material Twisted/Bent 5 5
No Flow 4 4
Device Handling Problem 4 4
Component Misassembled 4 4
Insufficient Flow or Under Infusion 4 4
Nonstandard Device 4 4
Disconnection 4 4
Material Fragmentation 3 3
Mechanical Problem 3 3
Crack 3 3
Contamination /Decontamination Problem 3 3
Patient Device Interaction Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Output Problem 2 2
Physical Resistance/Sticking 2 2
Unexpected Color 2 2
Air/Gas in Device 2 2
Lack of Effect 2 2
Appropriate Term/Code Not Available 2 2
Difficult to Open or Remove Packaging Material 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Contamination 2 2
Partial Blockage 2 2
Loose or Intermittent Connection 2 2
Entrapment of Device 2 2
Off-Label Use 2 2
Difficult to Remove 2 2
Patient-Device Incompatibility 2 2
Failure to Deliver 2 2
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Microbial Contamination of Device 1 1
Incomplete or Missing Packaging 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Product Quality Problem 1 1
Device Appears to Trigger Rejection 1 1
Delivered as Unsterile Product 1 1
Labelling, Instructions for Use or Training Problem 1 1
Misconnection 1 1
Backflow 1 1
Component Incompatible 1 1
Material Discolored 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Damaged by Another Device 1 1
Difficult to Advance 1 1
Separation Problem 1 1
Material Split, Cut or Torn 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 157 157
No Known Impact Or Consequence To Patient 59 59
Foreign Body In Patient 52 52
No Consequences Or Impact To Patient 30 30
No Patient Involvement 20 20
Insufficient Information 15 15
Device Embedded In Tissue or Plaque 14 14
No Information 7 7
Pain 4 4
Headache 3 3
Inadequate Pain Relief 3 3
Needle Stick/Puncture 3 3
No Code Available 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Patient Problem/Medical Problem 2 2
Blood Loss 2 2
Hematoma 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
Hemorrhage/Bleeding 1 1
Abscess 1 1
Cognitive Changes 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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