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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, microtiter diluting/dispensing
Product CodeJTC
Regulation Number 866.2500
Device Class 1

MDR Year MDR Reports MDR Events
2019 102 102
2020 2 2
2021 8 8
2022 26 26
2023 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 96 96
Patient Data Problem 59 59
Electrical Power Problem 57 57
Use of Device Problem 56 56
Installation-Related Problem 44 44
Structural Problem 27 27
Data Problem 26 26
Incorrect, Inadequate or Imprecise Result or Readings 18 18
False Negative Result 6 6
False Positive Result 2 2
Mechanical Problem 2 2
Difficult to Open or Close 2 2
Improper or Incorrect Procedure or Method 2 2
Application Network Problem 1 1
Unintended System Motion 1 1
Break 1 1
Collapse 1 1
Contamination 1 1
Positioning Failure 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 91 91
No Clinical Signs, Symptoms or Conditions 44 44
Test Result 7 7
No Consequences Or Impact To Patient 2 2
Injury 2 2
No Code Available 1 1
Insufficient Information 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Head Injury 1 1
Laceration(s) 1 1
Sprain 1 1
Tissue Damage 1 1
Burning Sensation 1 1
Concussion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Apr-20-2023
2 Becton Dickinson & Co. II Aug-30-2019
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