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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, specimen collection
Product CodeLIO
Regulation Number 866.2900
Device Class 1


Premarket Reviews
ManufacturerDecision
ARX SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD
  SUBSTANTIALLY EQUIVALENT 1
PURITAN MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 7 7
2015 2 2
2016 5 5
2017 6 6
2018 8 8
2019 2 2
2020 3 3
2021 11 11
2022 1 1
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Product Quality Problem 6 6
Leak/Splash 5 5
Insufficient Information 4 4
Material Protrusion/Extrusion 3 3
Improper or Incorrect Procedure or Method 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Entrapment of Device 1 1
Device Markings/Labelling Problem 1 1
Disconnection 1 1
Scratched Material 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Fluid/Blood Leak 1 1
Detachment of Device or Device Component 1 1
Nonstandard Device 1 1
Defective Device 1 1
Human Factors Issue 1 1
Device Handling Problem 1 1
Device Contamination With Biological Material 1 1
Chemical Spillage 1 1
Material Integrity Problem 1 1
Contamination 1 1
Human-Device Interface Problem 1 1
Difficult to Open or Close 1 1
Use of Device Problem 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 12 12
Exposure to Body Fluids 8 8
Laceration(s) 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Needle Stick/Puncture 5 5
No Consequences Or Impact To Patient 4 4
Insufficient Information 2 2
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
Chemical Exposure 2 2
Headache 2 2
Unspecified Infection 2 2
Chest Pain 1 1
Eye Injury 1 1
Blood Loss 1 1
No Code Available 1 1
Abrasion 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Remel, Inc III Aug-18-2009
2 Thomas Scientific II Nov-13-2020
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