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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
PAJUNK GMBH MEDIZINTECHNOLOGIE
  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 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Break 135 135
Leak/Splash 57 57
Device Markings/Labelling Problem 22 22
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 14 14
Fracture 12 12
Packaging Problem 12 12
Material Separation 9 9
Complete Blockage 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Material Integrity Problem 7 7
Nonstandard Device 6 6
No Flow 6 6
Material Twisted/Bent 6 6
Defective Device 6 6
Fluid/Blood Leak 5 5
Connection Problem 5 5
Material Deformation 5 5
Crack 4 4
Component Misassembled 4 4
Insufficient Flow or Under Infusion 4 4
Material Fragmentation 4 4
Device Handling Problem 4 4
Disconnection 4 4
Therapeutic or Diagnostic Output Failure 3 3
Contamination /Decontamination Problem 3 3
Patient Device Interaction Problem 3 3
Mechanical Problem 3 3
Loose or Intermittent Connection 3 3
Physical Resistance/Sticking 3 3
Entrapment of Device 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Infusion or Flow Problem 2 2
Improper Flow or Infusion 2 2
Lack of Effect 2 2
Unexpected Color 2 2
Partial Blockage 2 2
Patient-Device Incompatibility 2 2
Contamination 2 2
Failure to Deliver 2 2
Appropriate Term/Code Not Available 2 2
Air/Gas in Device 2 2
Difficult to Remove 2 2
Difficult to Open or Remove Packaging Material 2 2
Off-Label Use 2 2
Output Problem 2 2
Difficult to Advance 1 1
Component Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 173 173
No Known Impact Or Consequence To Patient 59 59
Foreign Body In Patient 57 57
No Consequences Or Impact To Patient 30 30
No Patient Involvement 20 20
Insufficient Information 19 19
Device Embedded In Tissue or Plaque 16 16
No Information 7 7
Pain 6 6
Needle Stick/Puncture 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Code Available 3 3
Inadequate Pain Relief 3 3
Headache 3 3
Patient Problem/Medical Problem 2 2
Death 2 2
Hematoma 2 2
Blood Loss 2 2
Injury 2 2
Exposure to Body Fluids 2 2
Discomfort 2 2
Tissue Damage 2 2
Cerebrospinal Fluid Leakage 2 2
Hemorrhage/Bleeding 2 2
Tingling 1 1
Cognitive Changes 1 1
Cardiac Arrest 1 1
Paresthesia 1 1
Chills 1 1
Numbness 1 1
Spinal Arachnoiditis 1 1
Abscess 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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