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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Product CodeMLA
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2018 1 1
2021 5 5
2022 4 4
2023 3 3
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 12 12
Incorrect, Inadequate or Imprecise Result or Readings 4 4
False Negative Result 4 4
Improper or Incorrect Procedure or Method 1 1
Chemical Spillage 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Leak/Splash 1 1
Break 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
Exposure to Body Fluids 1 1
Irritation 1 1
Laceration(s) 1 1
Chemical Exposure 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Feb-27-2017
2 Becton Dickinson & Co. II Jul-26-2013
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